Scientific publications

The staff and experts of the European Medicines Agency (EMA) publish articles on the Agency's scientific activities in scientific publications, such as journals or textbooks.

Access to the full text of the publications may be restricted to those who have an individual or institutional subscription. For more information on a particular publication, contact the corresponding author.

Jump to year


Back to top

Cave A., Kurz X., Arlett P, Real world data for regulatory decision making: challenges and possible solutions for Europe, Clin Pharmacol Ther. 2019 Apr 10. doi: 10.1002/cpt.1426. [Epub ahead of print]
De Wit M, Cooper C, Tugwell P, Bere N, Kirwan J, Conaghan PG, Roberts C, Aujoulat I, Al-Daghri N, Araujo de Carvalho I, Barker M, Bedlington N, Brandi ML, Bruyere O, Burlet N, Halbout P, Hiligsmann M, Jiwa F, Kanis JA, Laslop A, Lawrence W, Pinto D, Prieto Yerro C, Rabenda V, Rizzoli R, Scholte-Voshaar M, Vlaskoyska M. Reginster JY, Practical guidance for engaging patients in health research, treatment guidelines and regulatory processes: Results of an expert group meeting organized by the World Health Organization (WHO) and the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO), Aging Clin Exp Res (2019)

Gini R, Fournie X, Dolk H, et al. The ENCePP Code of Conduct: A best practise for scientific independence and transparency in noninterventional postauthorisation studies. Pharmacoepidemiol Drug Saf. 2019;1–12

Hedenmalm K, Slattery J, Skibicka-Stepien I, Kurz X, Morales D, Prescribing patterns of tramadol in adults in IMS® primary care databases in France and Germany between 1 January  2006 and 30 June 2016, Eur J Clin Pharmacol. 2019 Jan 23. doi: 10.1007/s00228-018-02622-9. [Epub ahead of print]
Hedenmalm K, Kurz X, Morales D, Effect of withdrawal of fusafungine from the market on prescribing of antibiotics and other alternative treatments in Germany: a pharmacovigilance impact study, Eur J Clin Pharmacol. 2019 Mar 5. doi: 10.1007/s00228-019-02650-z. [Epub ahead of print]
Jauregui B, Hudson LD, Becnel LB, Navarro Almario E, Fitzmartin R, Pétavy F, Seigneuret N, Malone JK, Zhou FL, Galvez J, Jackson T, Harmon N, Kush RD, The Turning Point for Clinical Research: Global Data Standardization, Applied Clinical Trials Online, 22 January 2019.
Morales DR, Slattery J, Pacurariu A, Pinheiro L, McGettigan P, Kurz X, Correction to: Relative and Absolute Risk of Tendon Rupture with Fluoroquinolone and Concomitant Fluoroquinolone/Corticosteroid Therapy: Population-Based Nested Case–Control Study, Clin Drug Investig. 2019 Feb;39(2):215. doi: 10.1007/s40261-019-00755-y.
Ollivier C, Thomson A, Manolis E, Blake K, Karlsson KE, Knibbe CAJ, Pons G, Hemmings R, Commentary on the EMA Reflection Paper on the use of extrapolation in the development of medicines for paediatrics, Br J Clin Pharmacol. 2019 Feb 1. doi: 10.1111/bcp.13883. [Epub ahead of print]
Olmo CA, McGettigan P, Kurz X, Barriers and opportunities for use of patient registries in medicines regulation, Clin Pharmacol Ther. 2019 Apr 10. doi: 10.1002/cpt.1414. [Epub ahead of print]
Pearson ADJ, Scobie N, Norga K, Ligas F, Chiodin D, Burke A, Minard-Colin V, Adamson P, Marshall LV, Balakumaran A0, Benettaib B, Bhargava P, Bollard CM, Bolotin E, Bomken S, Buechner J, Burkhardt B, Caron H, Copland C, Demolis P, Egorov A, Farhan M, Zugmaier G, Gross T, Horton-Taylor D, Klapper W, Lesa G, Marcus R, Miles RR, Nottage K, Pacaud L, Ricafort R, Schrappe M, Sterba J, Vezan R, Weiner S, Kim SY, Reaman G, Vassal G, ACCELERATE and European Medicine Agency Paediatric Strategy Forum for medicinal product development for mature B-cell malignancies in children, Eur J Cancer. 2019 Feb 14;110:74-85. doi: 10.1016/j.ejca.2019.01.013. [Epub ahead of print]
Selker HP, Eichler HG, Stockbridge NL, McElwee NE, Dere WH, Cohen T, Erban JK, Seyfert-Margolis VL, Honig PK, Kaitin KI, Oye KA, D'Agostino RB Sr, Efficacy and Effectiveness Too (EE2) Trials:Clinical Trial Designs to Generate Evidence on Efficacy and on Effectiveness in Wide Practice, Clin Pharmacol Ther. 2019 Jan 4. doi: 10.1002/cpt.1347. [Epub ahead of print]
Tanniou J, Smid SC, van der Tweel I, Teerenstra S, Roes KCB, Level of evidence for promising subgroup findings: the case of trends and multiple subgroups, Stat Med. 2019 Mar 13. doi: 10.1002/sim.8133. [Epub ahead of print]
Vannice KS, Cassetti MC, Eisinger RW, Hombach J, Knezevic I, Marston HD, Wilder-Smith A, Cavaleri M, Krause PR, Demonstrating vaccine effectiveness during a waning epidemic: a WHO/NIH meeting report on approaches to development and licensure of Zika vaccine candidates, Vaccine. 2019 Jan 10. pii: S0264-410X(18)31713-4. doi: 10.1016/j.vaccine.2018.12.040. [Epub ahead of print]


Back to top

Alteri E, Guizzaro L., Be open about drug failures to speed up research, Nature. 2018 Nov;563(7731):317-319 
Amaouche N., Casaert Salome H., Collignon O., Roldao Santos M., Ziogas C., Marketing authorisation applications submitted to the European Medicines Agency by small and medium-sized enterprises: an analysis of major objections and their impact on outcomes, Drug Discovery Today, Vol 23 (10), pp. 1801-1805, October 2018

Barkholt L., Voltz-Girolt C., Raine J., Salmonson T., Schüssler-Lenz M., Regulatory watch: European regulatory experience with advanced therapy medicinal products, Nat Rev Drug Discov. 2018 Nov 30. doi: 10.1038/nrd.2018.200. [Epub ahead of print]

Bahri P., Castillon Melero M., Listen to the public and fulfil their information interests - translating vaccine communication research findings into guidance for regulators, Br J Clin Pharmacol. 2018 Mar 24. doi: 10.1111/bcp.13587. [Epub ahead of print]
Bec G., Strecenski I., Castelnovo T., MAH compliance with post-authorisation obligations in the European Union: a five year review, Regulatory Rapporteur - Vol 15, No 11: 27-32
Blind E., Janssen H., Dunder K., de Graeff P.A., The European Medicines Agency's approval of new medicines for type 2 diabetes, Diabetes Obes Metab, 2018 May 8. doi: 10.1111/dom.13349. [Epub ahead of print]
Collignon O, Pétavy F., Statistical considerations about the design and endpoints of randomized clinical trials for children with irritable bowel syndrome. Neurogastroenterol Motil. 2018 May;30(5):e13266

Eichler HG, Barker R, Bedlington N, Bouvy JC, Broekmans AW, Bucsics A, Cerreta F, Corriol-Rohou S, Granados A, Le Cam Y, Schuurman A., The evolution of adaptiveness: balancing speed and evidence. Nat Rev Drug Discov. 2018 Jul 6. doi: 10.1038/nrd.2018.90. [Epub ahead of print]

Eichler HG, Bedlington N, Boudes M, Bouvy JC, Broekmans AW, Cerreta F, Faulkner SD, Forda S, Joos A, Le Cam Y, Mayer M, Pirard V, Corriol-Rohou S; ADAPT SMART Consortium., Medicines Adaptive Pathways to Patients: Why, when and how to engage?.Clin Pharmacol Ther. 2018 Jun 14. doi: 10.1002/cpt.1121. [Epub ahead of print]
Eichler HG, Bloechl-Daum B, Broich K, Kyrle PA, Oderkirk J, Rasi G, Santos Ivo R, Schuurman A, Senderovitz T, Slawomirski L, Wenzl M, Paris V. Data Rich, Information Poor: Can We Use Electronic Health Records to Create a Learning Healthcare System for Pharmaceuticals?, Clin Pharmacol Ther. 2019 Apr;105(4):912-922. doi: 10.1002/cpt.1226. Epub 2018 Oct 14
Eichler H.G., Sweeney F., The evolution of clinical trials: Can we address the challenges of the future? Clin Trials. 2018 Feb;15(1_suppl): 27-32.
Hwang T.J., Tomasi P.A., Bourgeois F.T., Delays in completion and results reporting of trials under the Paediatric Regulation in the European Union: cohort study, PLoS Med. 2018 Mar 1;15(3)
Kälviäinen R., Straus S., Dogne J.M., Bakchine S., Haas M., Reducing valproate use in women with epilepsy, The Lancet Neurology , Volume 17 , Issue 7 , 580-581
Kurz X., Perez‐Gutthann S., ENCePP Steering Group, Strengthening standards, transparency, and collaboration to support medicine evaluation: Ten years of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), Pharmacoepidemiol Drug Saf. 2018;1-11.
Moellenhoff K, Dette H, Kotzagiorgis E, Volgushev S, Collignon O., Regulatory assessment of drug dissolution profiles comparability via maximum deviation. Statistics in Medicine. 2018;1–14.
Morales D.R., Slattery J., Evans S., Kurz X., Antidepressant use during pregnancy and risk of autism spectrum disorder and attention deficit hyperactivity disorder: systematic review of observational studies and methodological considerations, BMC Med. 2018 Jan 15;16(1):6
Morales D.R., Slattery J., Pinheiro L., Kurz X., Hedenmalm K., Indications for Systemic Fluoroquinolone Therapy in Europe and Prevalence of Primary Care Prescribing in France, Germany and the UK: Descriptive Population Based Study, Clin Drug Investig.2018 Aug 24. doi: 10.1007/s40261-018-0684-7 [Epub ahead of print]

Morales DR, Slattery J, Pacurariu A, Pinheiro L, McGettigan P, Kurz X. Relative and Absolute Risk of Tendon Rupture with Fluoroquinolone and Concomitant Fluoroquinolone/Corticosteroid Therapy: Population-Based Nested Case-Control Study, Clin Drug Investig. 2019 Feb;39(2):205-213. doi: 10.1007/s40261-018-0729-y.

Nordenmalm S., Tomasi P., Pallidis C., More medicines for children - impact of the EU Paediatric Regulation, Arch Dis Child. 2018 Feb 28. pii: archdischild-2017-313309. doi: 10.1136/archdischild-2017-313309. [Epub ahead of print]

O'Connor DJ, Sheean ME, Hofer MP, Tsigkos S, Mariz S, Fregonese L, Larsson K, Hivert V, Westermark K, Naumann-Winter F, Stoyanova-Beninska V, Barišić I, Capovilla G, Magrelli A, Sepodes B, Defining orphan conditions in the context of the European orphan regulation: challenges and evolution, Nat Rev Drug Discov. 2019 Mar 22. doi: 10.1038/nrd.2018.128. [Epub ahead of print]

Ollivier C, Mulugeta YL, Ruggieri L, Saint-Raymond A, Yao L, Paediatric extrapolation: A necessary paradigm shift, Br J Clin Pharmacol. 2019 Apr;85(4):675-679. doi: 10.1111/bcp.13809. Epub 2018 Dec 18
Pacurariu A., Plueschke K., McGettigan P., et al., Electronic healthcare databases in Europe: descriptive analysis of characteristics and potential for use in medicines regulation, BMJ Open 2018;8:e023090. doi: 10.1136/bmjopen-2018-023090
Pacurariu A., Plueschke K., Olmo C.A., Kurz X., Imposed registries within the European postmarketing surveillance system: Extended analysis and lessons learned for regulators, Pharmacoepidemiol Drug Saf. 2018 May 11. doi: 10.1002/pds.4449 [Epub ahead of print]
Plueschke K., McGettigan P., Pacurariu A., Kurz X., Cave A., EU-funded initiatives for real world evidence: descriptive analysis of their characteristics and relevance for regulatory decision-making, BMJ Open. 2018 Jun 14;8(6)
Postigo R., Brosch S., Slattery J., van Haren A., Dogné J.M., Kurz X., Candore G., Domergue F., Arlett P., EudraVigilance Medicines Safety Database: Publicly Accessible Data for Research and Public Health Protection, Drug Saf. 2018 Mar 9. doi: 10.1007/s40264-018-0647-1. [Epub ahead of print]
Slattery J., Morales D., Pinheiro L., Kurz X.,Cohort Study of Psychiatric Adverse Events Following Exposure to Levonorgestrel-Containing Intrauterine Devices in UK General Practice, Drug Saf. 2018 May 21. doi: 10.1007/s40264-018-0683-x. [Epub ahead of print]
Tafuri G., Lucas I., Estevão S., Moseley J., d'Andon A., Bruehl H., Gajraj E., Garcia S., Hedberg N., Massari M., Molina A., Obach M., Osipenko L., Petavy F., Petschulies M., Pontes C., Russo P., Schiel A., Van de Casteele M., Zebedin-Brandl E.M., Rasi G., Vamvakas S., The impact of parallel regulatory-HTA scientific advice on clinical development. Assessing the uptake of regulatory and HTA recommendations, Br J Clin Pharmacol. 2018 Jan 25. doi: 10.1111/bcp.13524.
Vatzaki E., Straus S., Dogne H.M., Garcia Burgos J., Girard T., Martelletti P., Latest clinical recommendations on valproate use for migraine prophylaxis in women of childbearing age: overview from European Medicines Agency and European Headache Federation, The Journal of Headache and Pain (2018) 19:68


Back to top

Aartsma-Rus A., Balabanov P., Binetti L., Haas M., Haberkamp M., Mitchell J., Mário M.R., Muntoni F., Finkel R., Mercuri E., Stakeholder collaboration for spinal muscular atrophy therapy development, The Lancet Neurology , Vol 16(4), p. 264
Aartsma-Rus A., Straub V., Hemmings R., Haas M., Schlosser-Weber G., Stoyanova-Beninska V., Mercuri E., Muntoni F., Sepodes B., Vroom E., Balabanov P., Development of exon skipping therapies for Duchenne muscular dystrophy: a critical review and a perspective on the outstanding issues, Nucleic Acid Ther. 2017 Aug 10. doi: 10.1089/nat.2017.0682. [Epub ahead of print]
Aarum S., Hedman H., Hofer M. P., Koenig F., Mavris M., Posch M., Regnstrom J., Vamvakas S., Vetter T., Marketing authorisation of orphan medicines in Europe from 2000 to 2013, Science Direct, October 2017
Anton R., Haas M., Arlett P., Weise M., Balabanov P., Mazzaglia G., Prieto L., Keller-Stanislawski B., Raine J., Drug-induced progressive multifocal leukoencephalopathy in multiple sclerosis: European regulators' perspective, Clin Pharmacol Ther. 2016 Dec 21. doi: 10.1002/cpt.604
Bahri P., Fogd J., Morales D., Kurz X., ADVANCE consortium, Application of real-time global media monitoring and 'derived questions' for enhancing communication by regulatory bodies: the case of human papillomavirus vaccines, BMC Med. Vol. 15(1), p. 91, doi: 10.1186/s12916-017-0850-4.
Berger M.L., Sox H., Willke R.J., Brixner D.L., Eichler H.G., Goettsch W., Madigan D., Makady A., Schneeweiss S., Tarricone R., Wang S.V., Watkins J., Daniel Mullins C., Good practices for real-world data studies of treatment and/or comparative effectiveness: Recommendations from the joint ISPOR-ISPE Special Task Force on real-world evidence in health care decision making, Pharmacoepidemiol Drug Saf. 2017 Sep;26(9):1033-1039. doi: 10.1002/pds.4297.
Bonini S., Rasi G., Inhibitor of Fatty Acid Amide Hydrolase - Learning from Tragic Failures, N Engl J Med., Vol. 376(4):394.
Bouvy J.C., Blake K., Slattery J., De Bruin M.L., Arlett P., Kurz X., Registries in European post-marketing surveillance: a retrospective analysis of centrally approved products, 2005-2013, Pharmacoepidemiol Drug Saf. 2017 Mar 26.
Bueno H., de Graeff P., Richard-Lordereau I., Emmerich J., Fox K. A., Friedman C. P., Gaudin C., El-Gazayerly A., Goldman S., Hemmrich M., Henderson R. A., Himmelmann A., Irs A., Jackson N., James S. K., Katus H. A., Laslop A., Laws I., Mehran R., Ong S., Prasad K., Roffi M., Rosano G. M., Rose M., Sinnaeve P. R., Stough W. G., Thygesen K., Van de Werf F., Varin C., Verheugt F. W., de Los Angeles Alonso García M., Report of the European Society of Cardiology Cardiovascular Round Table regulatory workshop update of the evaluation of new agents for the treatment of acute coronary syndrome: Executive summary, Eur Heart J Acute Cardiovasc Care, pii: 2048872616649859
Collignon O., Veselý R., Should baseline-dependent cut-offs really be used to define disease improvement in juvenile idiopathic arthritis? And few other considerations, Rheumatology (Oxford), Vol. 56(1), pp.165-167.
Collignon O., Veselý R., Statistical considerations in the development of clinical predictive scores: comment on the article by Domsic et al, Arthritis Rheumatol., Vol. 69(1), pp. 241-242. doi: 10.1002/art.39854
De Briyne N., Gopal R., Diesel G., Iatridou D., O'Rourke D., Veterinary pharmacovigilance in Europe: a survey of veterinary practitioners, Veterinary Record Open, Vol. 4, Issue 1: e000224. doi: 10.1136/vetreco-2017-000224.
Goedecke T., Morales D., Pacurariu A., Kurz X., Measuring the impact of medicines regulatory interventions – systematic review and methodological considerations, British Journal of Clinical Pharmacology, doi: 10.1111/bcp.13469.
Kollb-Sielecka M, Demolis P., Emmerich J., Markey G., Salmonson T., Haas M., The European Medicines Agency review of pitolisant for treatment of narcolepsy: summary of the scientific assessment by the Committee for Medicinal Products for Human Use, sleepmedicine, Vol 33, pp. 125-129
Kurz X., Advancing regulatory science, advancing regulatory practice, Pharmacoepidemiol Drug Saf., doi: 10.1002/pds.4181.
Mazzaglia G., Straus S.M.J., Arlett P., da Silva D., Janssen H., Raine J., Alteri E., Study Design and Evaluation of Risk Minimization Measures: A Review of Studies Submitted to the European Medicines Agency for Cardiovascular, Endocrinology, and Metabolic Drugs, Drug Saf. 2017 Nov 9. doi: 10.1007/s40264-017-0604-4. [Epub ahead of print]
McCarthy D., Bahri P., Barnes J., Delumeau J.C., Edwards B., Harrison-Woolrych M., An Update on ISoP Special Interest Groups (SIGs), Drug Saf. 2017 Oct 4. doi: 10.1007/s40264-017-0603-5.
Medem A.V., Seidling H.M., Eichler H.G., Kaltschmidt J., Metzner M., Hubert C.M., Czock D., Haefeli W.E., Definition of variables required for comprehensive description of drug dosage and clinicalpharmacokinetics, Eur J Clin Pharmacol. Eur J Clin Pharmacol.Vol 73(5), pp. 633-641

Newbould V, Le Meur S, Goedecke T, Kurz X., Medication Errors: A Characterisation of Spontaneously Reported Cases in EudraVigilance, Drug Saf. 2017 Jul 11. doi: 10.1007/s40264-017-0569-3

Pauwels K., Huys I., Casteels M., Larsson K., Voltz C., Penttila K., More T., Simoens S., Are products with an orphan designation for oncology indications different from products for other rare indications? A retrospective analysis of European orphan designations granted between 2002-2012, Orphanet Journal of Rare Diseases, doi: 10.1186/s13023-017-0578-4
Pomba C., Rantala M., Greko C., Baptiste K. E., Catry B., van Duijkeren E., Mateus A., Moreno M. A., Pyörälä S., Ružauskas M., Sanders P., Teale C., Threlfall E. J., Kunsagi Z., Torren-Edo J., Jukes H., Törneke K., Public health risk of antimicrobial resistance transfer from companion animals, J Antimicrob Chemother, Vol. 72(4), pp. 957-968, doi: 10.1093/jac/dkw481
Postmus D., Richard S., Bere N., van Valkenhoef G., Galinsky J., Low E., Moulon I., Mavris M., Salmonsson T., Flores B., Hillege H., Pignatti F., Individual Trade-Offs Between Possible Benefits and Risks of Cancer Treatments: Results from a Stated Preference Study with Patients with Multiple Myeloma., Oncologist 2017 Oct 27. pii: theoncologist.2017-0257. doi: 10.1634/theoncologist.2017-0257. [Epub ahead of print]
Raimi-Abraham BT, de Orbe Izquierdo MS, Collignon O, Cerreta F, Regulatory considerations on the enrollment of older adults in oncology clinical trials, J Geriatr Oncol. 2017 May; 8(3):151-153. doi: 10.1016/j.jgo.2017.02.006, Epub 2017 Mar 9
Salmonson T., Dogné J. M., Janssen H., Garcia Burgos J., Blake P., Non-vitamin-K oral anticoagulants and laboratory testing: now and in the future: Views from a workshop at the European Medicines Agency (EMA), Eur Heart J Cardiovasc Pharmacother., Vol. 3(1), pp. 42–47.
Santoro A, Genov G, Spooner A, Raine J, Arlett P., Promoting and Protecting Public Health: How the European Union Pharmacovigilance System Works, Drug Saf. 2017 Jul 22. doi: 10.1007/s40264-017-0572-8
Smith M.Y., Russell A., Bahri P., Mol P.G.M., Frise S., Freeman E., Morrato E.H., The RIMES Statement: A Checklist to Assess the Quality of Studies Evaluating Risk Minimization Programs for Medicinal Products, Drug Saf. 2017 Dec 7. doi: 10.1007/s40264-017-0619-x. [Epub ahead of print].
Stefanska A.M., Distlerová D., Musaus J., Olski T.M., Dunder K., Salmonson T., Mentzer D., Müller-Berghaus J., Hemmings R., Veselý R., Extrapolation in the development of paediatric medicines: examples from approvals for biological treatments for paediatric chronic immune-mediated inflammatory diseases, Arch Dis Child. 2017 May 29. pii: archdischild-2016-312259. doi: 10.1136/archdischild-2016-312259
Tomasi P.A., Egger G.F., Saint-Raymond A, Enabling development of paediatric medicines in Europe: 10 years of the EU Paediatric Regulation, Paediatr Drugs. 2017 Sep 12. doi: 10.1007/s40272-017-0261-1.
Veselý R., Richardson P., The switch to infliximab biosimilars, The Lancet, doi:
Wickström K., Moseley J., Biomarkers and Surrogate Endpoints in Drug Development: A European Regulatory View, Invest Ophthalmol Vis Sci, Vol.58 (6), BIO27-BIO33.


Back to top

Bonini S., Rasi G., First-in-Human Clinical Trials - What We Can Learn from Tragic Failures, N Engl J Med. 2016 Nov 3;375(18):1788-1789.
Butlen-Ducuing F., Pétavy F., Guizzaro L., Zienowicz m., Haas M, Alteri E., Salmonson T., Corruble E., Regulatory watch: Challenges in drug development for central nervous system disorders: a European Medicines Agency perspective, Nat Rev Drug Discov., doi:10.1038/nrd.2016.237.
Cerreta F., Ankri J., Bowen D., Cherubini A., Cruz Jentoft A.J., Guðmundsson A., Haberkamp M., Jansen P., Marchionni N., Morgan S., Rönnemaa E., Petrovic M., Pilotto A., Rosa M., Wildiers H., Baseline frailty evaluation in drug development, J Frailty Aging., vol. 5(3), pp.139-140.
Ciani O., Buyse M., Drummond M., Rasi G., Saad E. D., Taylor R. S., Use of surrogate end points in healthcare policy: a proposal for adoption of a validation framework, Nat Rev Drug Discov. Vol 15(7), p. 516
Cox E., Cavaleri M., Eichler H.G., Woodcock J., Borio L., Facilitating Antibacterial Drug Development in a Time of Great Need, Clin Infect Dis. 63(suppl. 2), pp. S27-S28., doi: 10.1093/cid/ciw257
Donnelly H., Alemayehu D., Botgros R., Comic-Savic S., Eisenstein B., Lorenz B., Merchant K., Pelfrene E., Reith C., Santiago J., Tiernan R., Wunderink R., Tenaerts P., Knirsch C., Streamlining Safety Data Collection in Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia Trials: Recommendations of the Clinical Trials Transformation Initiative Antibacterial Drug Development Project Team, Clin Infect Dis. Vol. 63(suppl. 2), pp. S39-45., doi: 10.1093/cid/ciw316.
Eichler H.G., Hurts H., Broich K., Rasi G., Drug Regulation and Pricing - Can Regulators Influence Affordability?, N Engl J Med, Vol. 374, pp. 1807-1809. doi: 10.1056/NEJMp1601294.
Egger G.F., Wharton G.T., Malli S., Temeck J., Murphy M.D., Tomasi P., A Comparative Review of Waivers Granted in Pediatric Drug Development by FDA and EMA from 2007-2013, Therapeutic Innovation & Regulatory Science, doi: 10.1177/2168479016646809
Garcia-Larsen V., Del Giacco S.R., Moreira A., Bonini M., Haahtela T., Bonini S., Carlsen K.H., Agache I., Fonseca J., Papadopoulos N.G., Delgado L., Dietary intake and risk of asthma in children and adults: protocol for a systematic review and meta-analysis, Clin Transl Allergy. 2016 Apr 28;6:17. doi: 10.1186/ s13601-016-0106-y.
Goedecke T., Ord K., Newbould V., Brosch S., Arlett P., Medication Errors: New EU Good Practice Guide on Risk Minimisation and Error Prevention, Drug Saf., doi: 10.1007/s40264-016-0410-4
Gupta A., Mathad J. S., Abdel-Rahman S. M., Albano J. D., Botgros R., Brown V., Browning R. S., Dawson L., Dooley K. E., Gnanashanmugam D., Grinsztejn B., Hernandez-Diaz S., Jean-Philippe P., Kim P., Lyerly A. D., Mirochnick M., Mofenson L. M., Montepiedra G., Piper J., Sahin L., Savic R., Smith B., Spiegel H., Swaminathan S., Watts D. H., White A., Toward Earlier Inclusion of Pregnant and Postpartum Women in Tuberculosis Drug Trials: Consensus Statements From an International Expert Panel, Clin Infect Dis., doi: 10.1093/cid/civ991.
Gravanis I., Tzogani K., van Hennik P., de Graeff P., Schmitt P., Mueller-Berghaus J., Salmonson T., Gisselbrecht C., Laane E., Bergmann L., Pignatti F., The European Medicines Agency review of brentuximab vedotin (Adcetris) for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma or systemic anaplastic large cell lymphoma, Oncologist, Vol. 21(1), pp. 102-9.
Jutel M., Agache I., Bonini S., Burks A.W., Calderon M., Canonica W., Cox L., Demoly P., Frew A.J., O'Hehir R., Kleine-Tebbe J., Muraro A., Lack G., Larenas D., Levin M., Martin B.L., Nelson H., Pawankar R., Pfaar O., van Ree R., Sampson H., Sublett J.L., Sugita K., Du Toit G., Werfel T., Gerth van Wijk R., Zhang L., Akdis M., Akdis C.A., International Consensus on Allergen Immunotherapy II: Mechanisms, standardization, and pharmacoeconomics, J Allergy Clin Immunol. 2016 Feb;137(2):358-68. doi: 10.1016/j.jaci.2015.12.1300.
Knirsch C., Alemayehu D., Botgros R., Comic-Savic S., Friedland D., Holland T.L., Merchant K., Noel G.J., Pelfrene E., Reith C., Santiago J., Tiernan R., Tenearts P., Goldsack J.C., Fowler V.G. Jr., Improving Conduct and Feasibility of Clinical Trials to Evaluate Antibacterial Drugs to Treat Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Recommendations of the Clinical Trials Transformation Initiative Antibacterial Drug Development Project Team, Clin Infect Dis., Vol. 63 Suppl 2:S29-36. doi: 10.1093/cid/ciw258.
Luzon E., Blake K., Cole S., Nordmark A., Versantvoort C., Benlund E. G., Physiologically-Based Pharmacokinetic modelling in regulatory decision making at the European Medicines Agency, Clin Pharmacol Ther., doi: 10.1002/cpt.539
Maciá-Martínez M.A., de Abajo F. J., Roberts G., Slattery J., Thakrar B., Wisniewski A. F., An empirical approach to explore the relationship between measures of disproportionate reporting and relative risks from analytical studies, Drug Saf., Vol. 39(1), pp. 29-43.
Martinalbo J., Bowen D., Camarero J., Chapelin M., Démolis P., Foggi P., Jonsson B., Llinares J., Moreau A., O'Connor D., Oliveira J., Vamvakas S., Pignatti F., Early market access of cancer drugs in the EU, Ann Oncol., Vol. 27(1).
Mazzaglia G., Mol P., Drug Utilization research and risk management, in Elseviers M. et al., Drug Utilization Research - Methods and Applications, Wiley-Blackwell, May 2016, pp. 392-398.
Meeker-O'Connell A., Glessner C., Behm M., Mulinde J., Roach N., Sweeney F., Tenaerts P., Landray M. J., Enhancing clinical evidence by proactively building quality into clinical trials, Clin Trials., doi: 1740774516643491
Nair H., Ramilo O., Eichler I., Pelfrene E., Mejias A., Polack F. P., Pouwels K. B., Langley J. M., Nunes M., Van der Maas N., Kragten–Tabatabaie L., Baraldi E., Heikkinen T., Fauroux B., Sharland M., Park C., Manzoni P., Papadopoulos N. G., Martinón–Torres F., Stein R., Bont L., in collaboration with Respiratory Syncytial Virus Network (ReSViNET), Harmonization of RSV therapeutics – from design to performance, J. of Global Health, Vol. 6(1)., doi: 10.7189/jogh.06.010205
Papathanasiou P., Brassart L., Blake P., Hart A., Whitbread L., Pembrey R., Kieffer J., Transparency in drug regulation: public assessment reports in Europe and Australia, Drug Discovery Today, doi: 10.1016/j.drudis.2016.06.025.
Pearson A. D., Herold R., Rousseau R., Copland C., Bradley-Garelik B., Binner D., Capdeville R., Caron H., Carleer J., Chesler L., Geoerger B., Kearns P., Marshall L. V., Pfister S. M., Schleiermacher G., Skolnik J., Spadoni C., Sterba J., van den Berg H., Uttenreuther-Fischer M., Witt O., Norga K., Vassal G., Members of Working Group 1 of the Paediatric Platform of ACCELERATE; Implementation of mechanism of action biology-driven early drug development for children with cancer, Eur J Cancer, Vol 62, pp. 124-131
Pelfrene E., Willebrand E., Cavaleiro Sanches A., Sebris Z., Cavaleri M., Bacteriophage therapy: a regulatory perspective, J. Antimicrob. Chemother.,
doi: 10.1093/jac/dkw083.
Pinheiro L., Blake K., Januskiene J., Yue Q. Y., Arlett P., Geographical variation in reporting Interstitial Lung Disease as an adverse drug reaction: findings from an European Medicines Agency analysis of reports in EudraVigilance, doi: 10.1002/pds.3998.
Pita R., Ehmann F., Papaluca M., Nanomedicines in the EU - Regulatory Overview, AAPS J., doi: 10.1208/s12248-016-9967-1
Postmus D., Mavris M., Hillege H.L., Salmonson T., Ryll B., Plate A., Moulon I., Eichler H.G., Bere N., Pignatti F., Incorporating Patient Preferences Into Drug Development and Regulatory Decision Making: Results From a Quantitative Pilot Study With Cancer Patients, Carers, and Regulators, Clin Pharmacol Ther., Vol. 99(5), pp. 548-54.
Saint-Raymond A., Pelle B., Zaccaria C., Sennwitz M., Branch S., Usage of unpublished paediatric data, Arch Dis Child., Vol. 101(1), pp. 81-4.
Seabroke S., Candore G., Juhlin K., Quarcoo N., Wisniewski A., Arani R., Painter J., Tregunno P., Noren N., Slattery J., Performance of Stratified and Subgrouped Disproportionality. Analyses in Spontaneous Databases, Drug Saf., Vol. 39(4), pp. 355–364.
Slattery J., Measuring Signal Detection Performance: Can We Trust Negative Controls and Do We Need Them?, Vol. 39(5), pp. 371-3.
Spindler P., Bach K. F., Schmiegelow M., Bedlington N., Eichler H. G., Innovation of medical products: the evolution of regulatory science, research and education, Therapeutic Innovation & Regulatory Science, Vol. 50(1), pp. 44-48.
Straub V., Balabanov P., Bushby K., Ensini M., Goemans N., De Luca A., Pereda A., Hemmings R., Campion G., Kaye E., Arechavala-Gomeza V., Goyenvalle A., Niks E., Velldhuizen O., Furlong P., Stoyanova-Beninska V., Wood M. J., Johnson A., Mercuri E., Muntoni F., Sepodes B., Haas M., Vroom E., Aartsma-Rus A.. Stakeholder cooperation to overcome challenges in orphan medicine development: the example of Duchenne muscular dystrophy,The Lancet Neurology, Vol. 15(8), pp. 882–890.
Tafuri G., Pagnini M., Moseley J., Massari M., Petavy F., Behring A., Catalan A., Gajraj E., Hedberg N., Obach M., Osipenko L., Russo P., Van De Casteele M., Zebedin EM., Rasi G., Vamvakas S., How aligned are the perspectives of EU regulators and HTA bodies? A comparative analysis of regulatory-HTA parallel scientific advice, Br J Clin Pharmacol, doi: 10.1111/bcp.13023.
Tamborlane W.V., Haymond M.W., Dunger D., Shankar R., Gubitosi-Klug R., Bethin K., Karres J., Tomasi P., Libman I., Hale P.H., Portman R., Klingensmith G., Reed M., Blumer J., Giacoia G., Expanding Treatment Options for Youth with Type 2 Diabetes: Current Problems and Proposed Solutions, Diabetes Care, Vol. 39(3), pp. 323–329.
Van Riet-Nales D.A., Hussain N., Sundberg K.A., Eggenschwyler D., Ferris C., Robert J.L., Cerreta F., Regulatory incentives to ensure better medicines for older people: from ICH E7 to the EMA reflection paper on quality aspects, Int J Pharm. 2016 May 2. pii: S0378-5173(16)30367-2.
Vicini P., Fields O., Lai E., Litwack E. D., Martin A. M., Morgan T. M., Pacanowski M. A., Papaluca M., Perez O. D., Ringel M. S., Robson M., Sakul H., Vockley J., Zaks T., Dolsten M., Søgaard M., Precision Medicine in the Age of Big Data: The Present and Future Role of Large Scale Unbiased Sequencing in Drug Discovery and Development, Clin Pharmacol Ther., Vol. 99(2), pp. 198-207.
Wisniewski A.F.Z., Bate A., Bousquet C., Brueckner A., Candore G., Juhlin K., Marcia-Martinez M.A., Manlik K., Quarcoo N., Seabroke S., Slattery J., Southworth H., Thakrar B., Tregunno P., Van Holle L., Kayser M., Noren G.N., Good Signal Detection Practices: Evidence from IMI PROTECT, Drug Safety, doi: 10.1007/s40264-016-0405-1.


Back to top

Bahri P., Dodoo A. N., Edwards B. D., Edwards I. R., Fermont I., Hagemann U., Hartigan-Go K., Hugman B., Mol P. G., 'The ISoP CommSIG for Improving Medicinal Product Risk Communication: A New Special Interest Group of the International Society of Pharmacovigilance', Drug Saf., Vol. 38(7), pp. 621-627
Barnes P.J., Bonini S., Seeger W., Belvisi M.G., Ward B., Holmes A., Barriers to new drug development in respiratory disease, Eur Respir J. 2015 May;45(5):1197-207. doi: 10.1183/09031936.00007915
Bartlett J. A., Brewster M., Brown P., Cabral-Lilly D., Cruz C. N., David R., Eickhoff W. M., Haubenreisser S., Jacobs A., Malinoski F., Morefield E., Nalubola R., Prud'homme R. K., Sadrieh N., Sayes C. M., Shahbazian H., Subbarao N., Tamarkin L., Tyner K., Uppoor R., Whittaker-Caulk M., Zamboni W., 'Summary report of PQRI workshop on nanomaterial in drug products: current experience and management of potential risks', The AAPS Journal, Vol. 17(1), pp. 44-64.
Blind E., de Graeff P. A., Meurs I., Holtkamp F., Baczynska A., Janssen H., The European Medicines Agency's approval of proprotein convertase subtilisin/kexin type 9 inhibitors, Eur Heart J. pii: ehv673.
Bonelli M., Di Giuseppe F., Beken S., 'Impact analysis of ICH S9 on non-clinical development of anticancer drugs', Regul Toxicol Pharmacol., Vol. 73(1), pp. 361-366
Bonini M., Gramiccioni C., Fioretti D., Ruckert B., Rinaldi M., Akdis C., Todaro A., Palange P., Carlsen K.H., Pelliccia A., Rasi G., Bonini S., Asthma, allergy and the Olympics: a 12-year survey in elite athletes, AIDA and the Italian Unit of the GA2LEN Olympic Study, Curr Opin Allergy Clin Immunol. 2015 Apr;15(2):184-92. doi: 10.1097/ACI.0000000000000149
Both L., Botgros R., Cavaleri M., Analysis of licensed over-the-counter (OTC) antibiotics in the European Union and Norway, 2012, Euro Surveill., Vol. 20(34).
Bousquet J., Kuh D., Bewick M., Standberg T., Farrell J., Pengelly R., Joel M.E., Rodriguez Mañas L., Mercier J., Bringer J., Camuzat T., Bourret R., Bedbrook A., Kowalski M.L., Samolinski B., Bonini S. et al., Operational Definition of Active and Healthy Ageing (AHA): A Conceptual Framework, J Nutr Health Aging. 2015 Nov;19(9):955-60. doi: 10.1007/s12603-015-0589-6
Butlen-Ducuing F., Zienowicz M., Pétavy F., Haas M., Salmonson T., Eichler H.G., Rasi G., European regulatory experience with drugs for central nervous system disorders, Nat Rev Drug Discov., Vol14(2), pp. 89-90.
Catry B., Cavaleri M., Baptiste K., Grave K., Grein K., Holm A., Jukes H., Liebana E., Lopez Navas A., Mackay D., Magiorakos A. P., Moreno Romo M. A., Moulin G., Muñoz Madero C., Matias Ferreira Pomba M. C., Powell M., Pyörälä S., Rantala M., Ružauskas M., Sanders P., Teale C., Threlfall E. J., Törneke K., van Duijkeren E., Torren Edo J., Use of colistin-containing products in animals within the European Union and European Economic Area (EU/EEA): development of resistance and possible impact on human and animal health, Int J Antimicrob Agents, Vol 46(3), pp. 297-306.
Cohen J., Vincent J. L., Adhikari N. K. J., Machado F. R. , Angus D. C., Calandra T., Jaton K., Giulieri S., Delaloye J., Opal S., Tracey K., van der Poll T., Pelfrene E., 'Sepsis: a roadmap for future research', Lancet Infect Dis., doi:
Dal Pan G. J., Arlett P. R., 'The US Food and Drug Administration-European Medicines Agency collaboration in pharmacovigilance: common objectives and common challenges', Drug Saf., Vol. 38, pp. 13-15.
Dodt J., Hubbard A. R., Wicks S. J., Gray E., Neugebauer B., Charton E., Silvester G., 'Potency determination of factor VIII and factor IX for new product labelling and postinfusion testing: challenges for caregivers and regulators', Haemophilia, doi: 10.1111/hae.12634.
Ehmann F., Caneva L., Prasad K., Paulmichl M., Maliepaard M., Llerena A., Ingelman-Sundberg M., Papaluca-Amati M., 'Pharmacogenomic information in drug labels: European Medicines Agency perspective', Br J Clin Pharmacol., doi:10.1038/tpj.2014.86.
Ehmann F., Papaluca M., Di Giuseppe F., Pani L., Eskova A., Manolis E., Herold R., 'Changes and determination of dosing recommendations for medicinal products recently authorised in the European Union', Expert Opin Pharmacother, Vol.16(6), pp. 903-11.
Eichler H. G., Baird L., Barker R., Bloechl-Daum B., Børlum-Kristensen F., Brown J., Chua R., Del Signore S., Dugan U., Ferguson J., Garner S., Goettsch W., Haigh J., Honig P., Hoos A., Huckle P., Kondo T., Le Cam Y., Leufkens H., Lim R., Longson C., Lumpkin M., Maraganore J., O'Rourke B., Oye K., Pezalla E., Pignatti F., Raine J., Rasi G., Salmonson T., Samaha D., Schneeweiss S., Siviero P., Skinner M., Teagarden J., Tominaga T., Trusheim M., Tunis S., Unger T., Vamvakas S., Hirsch G., 'From adaptive licensing to adaptive pathways: delivering a flexible life span approach to bring new drugs to patients', Clin Pharmacol Ther., Vol. 97(3), pp. 234-46.
Eichler H.G, Thomson A., Eichler I., Schneeweiss S., 'Assessing the relative efficacy of new drugs: an emerging opportunity', Nature Reviews Drug Discovery, Vol. 14, pp. 443–444.
Goldman M., Seigneuret N., Eichler H. G., 'The Innovative Medicines Initiative: An engine for regulatory science', Nat Rev Drug Discov., Vol. 14(1), pp.1-2
Gupta A., Mathad J.S., Abdel-Rahman S.M., Albano J.D., Botgros R., Brown V., Browning R.S., Dawson L., Dooley K.E., Gnanashanmugam D., Grinsztejn B., Hernandez-Diaz S., Jean-Philippe P., Kim P., Lyerly A.D., Mirochnick M., Mofenson L.M., Montepiedra G., Piper J., Sahin L., Savic R., Smith B., Spiegel H., Swaminathan S., Watts D.H., White A., 'Toward Earlier Inclusion of Pregnant and Postpartum Women in Tuberculosis Drug Trials: Consensus Statements From an International Expert Panel', Clin Infect Dis. 2015 Dec 9. pii: civ991.
Haas M., Mantua V., Haberkamp M., Pani L., Isaac M., Butlen-Ducuing F., Vamvakas S., Broich K., The European Medicines Agency's strategies to meet the challenges of Alzheimer disease, Nat Rev Drug Discov. 2015 Apr;14(4):221-2. doi: 10.1038/nrd4585
Haas M., Vlcek V., Balabanov P., Salmonson T., Bakchine S., Markey G., Weise M., Schlosser-Weber G., Brohmann H., Yerro C. P., Mendizabal M. R., Stoyanova-Beninska V., Hillege H. L., 'The European Medicines Agency review of ataluren for the treatment of ambulant patients aged 5 years and older with Duchenne muscular dystrophy resulting from a nonsense mutation in the dystrophin gene: Summary of the scientific assessment of the Committee for Medicinal Products for Human Use', Neuromuscul Disord. Vol. 25(1), pp.5-13
Hanaizi Z., Flores B., Hemmings R., Camarero J., Sancho-Lopez A., Salmonson T., Gisselbrecht C., Laane E., Pignatti F.,' The European Medicines Agency review of pomalidomide for the treatment of adult patients with multiple myeloma: Summary of the scientific assessment of the Committee for Medicinal Products for Human Use', Oncologist, Vol. 20(3), pp. 329-334.
Haubenreisser s., Harvey-Allchurch M., Chapter 3 - The European Medicines Agency and the Regulation of Medicines in the European Union, Food and Drug Regulation in an Era of Globalised Marekts, pp. 25-36.
Hofer M.P., Jakobsson C., Zafiropoulos N., Vamvakas S., Vetter T., Regnstrom J., Hemmings R.J., Regulatory watch: Impact of scientific advice from the European Medicines Agency, Nature Reviews Drug Discovery, Vol 14(5), pp. 302-303.
Klug B., Celis P., Ruepp R., Robertson J S., EU regulatory guidelines for the clinical evaluation of adjuvants, Clin Res Pr Drug Regul Aff, doi:10.3109/10601333.2015.1001899
Koenig F., Slattery S., Groves T., Lang T., Benjamini Y., Day S., Bauer P., and Posch M., Sharing clinical trial data on patient level: Opportunities and challenges, Biometrical Journal 57, 8-26, (2015) [bib]
Krause P. R., Cavelari M., Coleman G., Gruber M. F., Approaches to Demonstration of Ebola Virus Vaccine Efficacy, Lancet, Vo. 15(6), pp. 615-746.
Loth E., Spooren W., Ham L. M., Isaac M. B., Auriche-Benichou C., Banaschewski T., Baron-Cohen S., Broich K., Bölte S., Bourgeron T., Charman T., Collier D., de Andres-Trelles F., Durston S., Ecker C., Elferink A., Haberkamp M., Hemmings R., Johnson M. H., Jones E. J., Khwaja O. S., Lenton S., Mason L., Mantua V., Meyer-Lindenberg A., Lombardo M. V., O'Dwyer L., Okamoto K., Pandina G. J., Pani L., Persico A. M., Simonoff E., Tauscher-Wisniewski S., Llinares-Garcia J., Vamvakas S., Williams S., Buitelaar J. K., Murphy D. G., Identification and Validation of Biomarkers for Autism Spectrum Disorders, Nat Rev Drug Discov. Vol 15(1), pp. 70-3.
Luciani F., Galluzzo S., Gaggioli A., Kruse N. A., Venneugues P., Schneider C. K., Pini C., Melchiorri D., Implementing quality by design for biotech products: are regulators on track?, Vol 7(3), pp. 451-455
Luigetti R., Cooke E., Cuddy B., Goux S., Rees I., GMP Oversight of Medicines Manufacturers in the European Union, PDA Letter
Murray S., McKenna L., Pelfrene E., Botgros R., Accelerating clinical drug development for children with tuberculosis, International Journal of Tuberculosis and Lung Disease., 2015 Dec;19 Suppl 1, pp. 69-74.
Nachman S., Ahmed A., Amanullah F., Becerra M. C., Botgros R., Brigden G., Browning R., Gardiner E., Hafner R., Hesseling A., How C., Jean-Philippe P., Lessem E., Makhene M., Mbelle N., Marais B., McIlleron H., McNeeley D. F., Mendel C., Murray S., Navarro E., Anyalechi E. G., Porcalla A. R., Powell C., Powell M., Rigaud M, Rouzier V., Samson P., Schaaf H. S., Shah S., Starke J., Swaminathan S., Wobudeya E., Worrell C., Towards early inclusion of children in tuberculosis drugs trials: a consensus statement, Lancet Infect Dis., Vol. 15(6), pp. 711–720.
Offringa M., Davis J.M., Turner M.A., Ward R., Bax R., Maldonado S., Sinha V., McCune S.K., Zajicek A., Benjamin D.K., Bucci-Rechtsweg C., Nelson R.M., Applying Regulatory Science to Develop Safe and Effective Medicines for Neonates: Report of the US Food and Drug Administration First Annual Neonatal Scientific Workshop, October 28-29, 2014, Therapeutic Innovation & Regulatory Science, 7 August 2015
Oye K.A., Pearson M., Eichler H.G., Mullin T., Hoos A., Managing uncertainty in drug development and use informed regulation: Enhancing adaptability and flexibility in pharmaceuticals regulation. In: Improving Risk Regulation, International Risk Governance Council (IRGC). Lausanne: IRGC, 2015 (63-80).
Pacurariu A.C., Straus S.M., Trifirò G., Schuemie M.J., Gini R., Herings R., Mazzaglia G., Picelli G., Scotti L., Pedersen L., Arlett P., Van der Lei J., Sturkenboom M.C., Coloma P.M., Useful Interplay Between Spontaneous ADR Reports and Electronic Healthcare Records in Signal Detection, Drug Saf., doi:10.​1007/​s40264-015-0341-5, doi:10.1586/17512433.2015.1028918
Papaluca M., Grecoa M., Tognana E., Ehmann F., Saint-Raymond A., White spots in pharmaceutical pipelines–EMA identifies potential areas of unmet medical needs, Expert Review of Clinical Pharmacology, Vol.8, Issue 3, 2015
Pelfrene E., Pinheiro M. H., Cavaleri M., 'Artemisinin-based combination therapy in the treatment of uncomplicated malaria: review of recent regulatory experience at the European Medicines Agency', Int Health, doi: 10.1093/inthealth/ihv017.
Pignatti F., Ashby D., Brass E. P., Eichler H. G., Frey P., Hillege H. L., Hori A., Levitan B., Liberti L., Löfstedt R. E., McAuslane N., Micaleff A., Noel R. A., Postmus D., Renn O., Sabourin B. J., Salmonson T., Walker S., Structured Frameworks to Increase the Transparency of the Assessment of Benefits and Risks of Medicines: Current Status and Possible Future Directions, Vol. 98(5), pp. 522-33.
Rasi G., Bonini S., Innovative medicines: new regulatory procedures for the third millennium, Expert Opin Biol Ther. 2015;15 Suppl 1:S5-8. doi: 10.1517/14712598.2015.1026322
Rottenkolber M., Voogd E., van Dijk L., Primatesta P., Becker C., Schlienger R., de Groot M. C., Alvarez Y., Durand J., Slattery J., Afonso A., Requena G., Gil M., Alvarez A., Hesse U., Gerlach R., Hasford J., Fischer R., Klungel O. H., Schmiedl S., 'Time trends of period prevalence rates of patients with inhaled long-acting Beta-2-agonists-containing prescriptions: a European comparative database study', PLoS One, Vol.10(2):e0117628.
Salmikangas P., Menezes-Ferreira M., Reischl I., Tsiftsoglou A., Kyselovic J., Borg J. J., Ruiz S., Flory E., Trouvin J. H., Celis P., Ancans J., Timon M., Pante G., Sladowski D., Lipnik-Stangelj M., Schneider C. K., 'Manufacturing, characterisation and control of cell-based medicinal products: challenging paradigms towards commercial use', Regen. Med., Vol. 10(1), pp. 65-78.
Samardzic J., Turner M.A., Bax R., Allegaert K., Neonatal Medicines Research: Challenges and Opportunities, Expert Opin Drug Metab Toxicol. 2015 Jul;11(7):1041-52
Segec A., Keller-Stanislawski B., Vermeer N.S., Macchiarulo C., Straus S.M., Hidalgo-Simon A., De Bruin M.L., Strategy in Regulatory Decision-Making for Management of Progressive Multifocal Leukoencephalopathy, Clinical Pharmacology & Therapeutics, Vol. 98(5), pp. 502-505.
Torneke K., Torren-Edo J., Grave K., Mackay D. K., The management of risk arising from the use of antimicrobials in veterinary medicine in EU/EEA countries – a review, J Vet Pharmacol Ther. doi: 10.1111/jvp.12226.
Torren E. J., Grave K., Mackay D., '“One Health”: the regulation and consumption of antimicrobials for animal use in the EU', IAHJ, Vol. 2, pp.14-16.
Vermeer N.S., Straus S.M.J.M., Mantel-Teeuwisse A.K., Hidalgo-Simon A., Egberts A.C.G., Leufkens H.G.M., De Bruin M.L., Drug-induced progressive multifocal leukoencephalopathy: Lessons learned from contrasting natalizumab and rituximab, Clinical Pharmacology and Therapeutics, Vol. 98(5), pp. 542-550.
Walton M. K., Powers J. H. 3rd, Hobart J., Patrick D., Marquis P., Vamvakas S., Isaac M., Molsen E., Cano S., Burke L. B., Clinical Outcome Assessments: Conceptual Foundation-Report of the ISPOR Clinical Outcomes Assessment - Emerging Good Practices for Outcomes Research Task Force, Value Health Vol18, pp. 741-52.


Back to top

Aartsma-Rus A., Ferlini A., Goemans N., Pasmooij A. M., Wells D. J., Bushby K., Vroom E., Balabanov P., 'Translational and regulatory challenges for exon skipping therapies', Human Gene Therapy, Vol. 25(10), pp. 885-92.
Abbing-Karahagopian V., Huerta C., Souverein P. C., de Abajo F., Leufkens H. G., Slattery J., Alvarez Y., Miret M., Gil M., Oliva B., Hesse U., Requena G., de Vries F., Rottenkolber M., Schmiedl S., Reynolds R., Schlienger R. G., de Groot M. C., Klungel O. H., van Staa T. P., van Dijk L., Egberts A. C., Gardarsdottir H., De Bruin M. L., 'Antidepressant prescribing in five European countries: application of common definitions to assess the prevalence, clinical observations, and methodological implications', Eur J Clin Pharmacol, Vol. 70(7), pp. 849-857.
Abbing-Karahagopian V., Kurz X., de Vries F., van Staa T. P., Alvarez Y., Hesse U., Hasford J., van Dijk L., de Abajo F. J., Weil J. G., Grimaldi-Bensouda L., Egberts A. C., Reynolds R. F., Klungel O. H., 'Bridging differences in outcomes of pharmacoepidemiological studies: Design and first results of the Protect project', Curr Clin Pharmacol, Vol 9, pp. 130-138.
Arlett P., Portier G., de Lisa R., Blake K., Wathion N., Dogne J. M., Spooner A., Raine J., Rasi G., 'Proactively managing the risk of marketed drugs: experience with the EMA Pharmacovigilance Risk Assessment Committee', Nat Rev Drug Discov, Vol. 13(5), pp. 395-397.
Arlett .P, Postigo R., Janssen H., Spooner A., 'Periodic Benefit-Risk Evaluation Report: A European Union Regulatory Perspective'. Pharmaceutical Medicine', Vol. 28(6), pp. 309-315.
Arlett P., Sarac S. B., Thomson A., Davies C., Teixeira T., Blake K. V., Stenver D., 'The European Medicines Agency's use of prioritised independent research for best evidence in regulatory action on diclofenac', Pharmacoepidemiol Drug Saf, Vol. 23(4), pp. 431-434.
Baird L. G., Banken R., Eichler H. G., Kristensen F. B., Lee D. K., Lim J. C., Lim R., Longson C., Pezalla E., Salmonson T., Samaha D., Tunis S., Woodcock J., Hirsch G., 'Accelerated access to innovative medicines for patients in need', Clin Pharmacol Ther, Vol. 96(5), pp. 559–571.
Balabanov P., Haas M., Elferink A., Bakchine S., Broich K., 'Addressing the regulatory and scientific challenges in multiple sclerosis - a statement from the EU regulators', Mult Scler, Vol. 20(10), pp. 1282-1287.
Beckmann J., Hagemann U., Bahri P., Bate A., Boyd I. W., Dal Pan G. J., Edwards B. D., Edwards I. R., Hartigan-Go K., Lindquist M., McEwen J., Moride Y., Olsson S., Pal S. N., Soulaymani-Bencheikh R., Tuccori M., Vaca C. P., Wong I. C. K., 'Teaching pharmacovigilance: the WHO-ISoP core elements of a comprehensive modular curriculum', Drug Saf, Vol. 37(10), pp. 743-759.
Berntgen M., Gourvil A., Pavlovic M., Goettsch W., Eichler H.-G., Kristensen F. B., 'Improving the contribution of regulatory assessment reports to health technology assessments - a collaboration between the European Medicines Agency and the European Network for Health Technology Assessment', Value in Health, Vol. 17(5), pp. 634-641.
Blake K. V., Zaccaria C., Domergue F., La Mache E., Saint-Raymond A., Hidalgo-Simon A., 'Comparison between paediatric and adult suspected adverse drug reactions reported to the European Medicines Agency: implications for pharmacovigilance', Pediatric Drugs, Vol. 16(4), pp. 309-319.
Bonini S., Eichler H. G., Wathion N., Rasi G., 'Transparency and the European Medicines Agency – sharing of clinical trial data', N Engl J Med, Vol. 371(26), pp. 2452-2455.
Borg J. J., Tomasi P., Pani L., Aislaitner G., Pirozynski M., Leufkens H., Melchiorri D., 'Licensing of generic medicines: are there any challenges left? A pharmaceutical regulatory perspective', Sci Pharm, Vol. 82, pp. 847-856.
Butlen-Ducuing F., Zienowicz M., Pétavy F., Haas M., Salmonson T., Eichler H., Rasi G., 'European regulatory experience with drugs for central nervous system disorders', Nat Rev Drug Discov, doi: 10.1038/nrd4511.
Caneva L., Bonelli M., Papaluca-Amati M., Vidal J. M., 'Critical review on the environmental risk assessment of medicinal products for human use in the centralised procedure', Regul Toxicol Pharmacol, Vol. 68(3), pp. 312-316.
Cerreta F., Temple R., Asahina Y., Connaire C., 'Regulatory activities to address the needs of older patients', J Nutr Health Aging, doi: 10.1007/s12603-014-0494-4.
Cortes-Blanco .A, Prieto-Yerro C., Martinez-Lazaro R., Zamora J., Jiménez-Huete A., Haberkamp M., Pohly J., Enzmann H., Zinserling J., Strassmann V., Broich K.. 'Florbetapir (18F) for brain amyloid positron emission tomography: Highlights on the European marketing approval', Alzheimers Dement., Vol. 10(5 Suppl), pp. S395-9.
de Groot M. C., Schuerch M., de Vries F., Hesse U., Oliva B., Gil M., Huerta C., Requena G., de Abajo F., Afonso A. S., Souverein P. C., Alvarez Y., Slattery J., Rottenkolber M., Schmiedl S., Van Dijk L., Schlienger R. G., Reynolds R., Klungel O. H., 'Antiepileptic drug use in seven electronic health record databases in Europe: A methodologic comparison', Epilepsia, Vol. 55(5), pp. 666-673.
Egan A. G., Blind E., Dunder K., de Graeff P. A., Hummer B. T., Bourcier T., Rosebraugh C., 'Pancreatic safety of incretin-based drugs — FDA and EMA assessment', N Engl J Med, Vol. 370(9), pp. 794-797.
Egger G. F., Manent N., 'Re: Non-publication and delayed publication of randomized trials on vaccines: survey', BMJ, 2014, Vol. 348, g3058.
Eichler H. G., Baird L. G., Barker R., Bloechl-Daum B., Børlum-Kristensen F., Brown J., Chua R., Del Signore S., Dugan U., Ferguson J., Garner S., Goettsch W., Haigh J., Honig P., Hoos A., Huckle P., Kondo T., Le Cam Y., Leufkens H., Lim R., Longson C., Lumpkin M., Maraganore J., O'Rourke B., Oye K., Pezalla E., Pignatti F., Raine J., Rasi G., Salmonson T., Samaha D., Schneeweiss S., Siviero P. D., Skinner M., Teagarden J. R., Tominaga T., Trusheim M. R., Tunis S., Unger T. F, Vamvakas S., Hirsch G., 'From adaptive licensing to adaptive pathways: delivering a flexible life-span approach to bring new drugs to patients', Clin Pharmacol Ther, DOI: 10.1002/cpt.59.
Eichler H. G., Oye K., Baird L. G., Abadie E., Brown J., Drum C. L., Ferguson J., Garner S., Honig P., Hukkelhoven M., Lim J. C., Lim R., Lumpkin M. M., Neil G., O'Rourke B. ,Pezalla E., Shoda D., Seyfert-Margolis V., Sigal E. V., Sobotka J., Tan D., Unger T. F., Hirsch G., Adaptive licensing: taking the next step in the evolution of drug approval', Clin Pharmacol Ther, Vol. 91(3), pp. 426-37.
Franco P., Porta N., Holliday J. D., Willett P., 'The use of 2D fingerprint methods to support the assessment of structural similarity in orphan drug legislation', J Cheminform, Vol. 6(1): 5.
Gravanis I., Vleminckx C., Jonsson B., Pignatti F., 'The changing world of oncology dug development: the regulatory bodies' perspective', Chin Clin Oncol, Vol. 3(2), p. 22.
Grave K., Mackay D., Muller A., Torren-Edo J., 'European Surveillance of Veterinary Antimicrobial Consumption (ESVAC): Establishment of the project and key outputs', Regulatory Rapporteur, Vol. 11(9), pp. 4-9.
Grave K., Torren-Edo J., Muller A., Greko C., Moulin G., Mackay D., ESVAC Group, 'Variations in the sales and sales patterns of veterinary antimicrobial agents in 25 European countries', J Antimicrob Chemother, Vol. 69(8), pp. 2284-2291.
Hampson L. V., Herold R., Posch M., Saperia J., Whitehead A., 'Bridging the gap: A review of dose-investigations in paediatric investigation plans', Br J Clin Pharmacol, Vol. 78(4), pp. 898–907.
Hanaizi Z., Unkrig C., Enzmann H., Camarero J., Sancho-Lopez A., Salmonson T., Gisselbrecht C., Laane E., Pignatti F., 'The European Medicines Agency review of bosutinib for the treatment of adult patients with chronic myelogenous leukaemia: Summary of the scientific assessment of the Committee for Medicinal Products for Human Use', Oncologist., Vol.19(4), pp. 421-5.
Herold R., Saint-Raymond A., Norga K., 'Too few medicines for children with cancer', JAMA Pediatr., Vol.168(6), p. 583.
Hill D. L., Schwarz A. J., Isaac M., Pani L., Vamvakas S., Hemmings R., Carrillo M. C., Yu P., Sun J., Beckett L., Boccardi M., Brewer J., Brumfield M., Cantillon M., Cole P. E., Fox N., Frisoni G. B., Jack C., Kelleher T., Luo F., Novak G., Maguire P., Meibach R., Patterson P., Bain L., Sampaio C., Raunig D., Soares H., Suhy J., Wang H., Wolz R., Stephenson D., 'Coalition Against Major Diseases / European Medicines Agency biomarker qualification of hippocampal volume for enrichment of clinical trials in predementia stages of Alzheimer's disease', Alzheimers Dement, Vol. 10(4), pp. 421-429.
Kurki P., Bielsky M.C.; Working Party on Similar Biological (Biosimilar) Medicinal Products (BMWP) of Committee for Medicinal Products for Human Use (CHMP), 'Letter to the editor: ECCO position challenged by European drug regulators', J Crohns Colitis. 2014 Mar;8(3):258
Lincker H., Ziogas C., Carr M., Porta N., Eichler, H. G., 'Regulatory watch: Where do new medicines originate from in the EU?', Nat Rev Drug Discov, Vol. 13(2), pp. 92-93.
Mackay D., Grave K., Muller A., Torren-Edo J., 'Key success factors for surveys of antimicrobial sales and use in the European Union', in proceeding: 'Responsible and prudent use of antimicrobial agents for animals. International solidarity to fight against antimicrobial resistance', OIE Global Conference, Paris, France, 13-15 March 2013, pp. 28-31.
Mariz S., Tsigkos S., Fregonese L., Aarum S., Dehlink R., Llinares J., Sepodes B., 'The orphan framework as a new opportunity: an expert opinion', Informa healthcare, Vol. 2(11 ), pp. 1181-1186.
Mentzer D., Desfontaine E., Tomasi P. A., 'The importance and challenge of pediatric trials of hemophilia drugs', Nat Med., doi:10.1038/nm.3546
Nofziger C., Papaluca M., Terzic A., Waldman S., Paulmichl M., 'Policies to aid the adoption of personalized medicine', Nat Rev Drug Discov, Vol. 13(3), pp. 159-160.
Pacurariu A.C., Coloma P. M., van Haren A., Genov G., Sturkenboom M. C., Straus S. M., 'A description of signals during the first 18 months of the EMA Pharmacovigilance Risk Assessment Committee', Drug Saf., Vol. 37(12), pp.1059-66.
Pignatti F., Jonsson B., Blumenthal G., Justice R., 'Assessment of benefits and risks in development of targeted therapies for cancer - The view of regulatory authorities', Mol Oncol., pii: S1574-7891(14)00242-7
Peschel W., 'The use of community herbal monographs to facilitate registrations and authorisations of herbal medicinal products in the European Union 2004-2012', J Ethnopharmacol, doi: 10.1016/j.jep
Pfleiderer M., Trouvin J. H., Brasseur D., Gränstrom M., Shivji R., Mura M., Cavaleri M., 'Brief Report for Vaccine - Summary of knowledge gaps related to quality and efficacy of current influenza vaccines', Vaccine., Vol 32(35), pp. 4586-91.
Pignatti F., Ehmann F., Hemmings R., Jonsson B., Nuebling M., Papaluca-Amati M., Posch M., Rasi G., 'Cancer drug development and the evolving regulatory framework for companion diagnostics in the European Union', Clin Cancer Res. Vol. 20(6), pp.1458-68.
Quijano Ruiz B., Desfontaine E., Arenas-López S., Wang S., 'Pediatric formulation issues identified in paediatric investigation plans', Expert Rev Clin Pharmacol, Vol. 7(1), pp. 25-30.
Requena G., Abbing-Karahagopian V., Huerta C., De Bruin M. L., Alvarez Y., Miret M., Hesse U., Gardarsdottir H., Souverein P. C., Slattery J., Schneider C., Rottenkolber M., Schmiedl S., Gil M., De Groot M. C., Bate A., Ruigómez A., García Rodríguez L. A., Johansson S., de Vries F., Montero D., Schlienger R., Reynolds R., Klungel O. H., de Abajo F. J., 'Trends in incidence rates of hip and femur fractures in five European countries, 2003-2009: a comparison using electronic health care records databases', Calcif Tissue Int., Vol. 94(6), pp. 580-9.
Requena G., Abbing-Karahagopian V., Huerta C., De Bruin M. L., Alvarez Y., Miret M., Hesse U., Gardarsdottir H., Souverein P. C., Slattery J., Schneider C., Rottenkolber M., Schmiedl S., Gil M., De Groot M. C., Bate A., Ruigómez A., García Rodríguez L. A., Johansson S., de Vries F., Montero D., Schlienger R., Reynolds R., Klungel O. H., de Abajo F. J., 'Incidence rates and trends of hip/femur fractures in five European countries: comparison using e-healthcare records databases', Calcif Tissue Int, Vol. 94(6), pp. 580-589.
Selker H. P., Oye K. A., Eichler H. G., Stockbridge N. L., Mehta C. R., Kaitin K. I., McElwee N. E., Honig P. K., Erban J. K., D'Agostino R. B. 'A proposal for integrated efficacy-to-effectiveness (E2E) clinical trials', Clin Pharmacol Ther, Vol. 95(2), pp. 147-153.
Sun H., Vesely R., Nelson R. M., Taminiau J., Szitanyi P., Isaac M., Klein A., Uzu S., Griebel D., Mulberg A. E., International Inflammatory Bowel Disease Working Group, 'Steps toward harmonization for clinical development of medicines in pediatric ulcerative colitis-a global scientific discussion, part 2: data extrapolation, trial design, and pharmacokinetics', J Pediatr Gastroenterol Nutr, Vol. 58(6), pp. 684-688.
Sun H., Vesely R., Taminiau J., Szitanyi P., Papadopoulos E. J., Isaac M., Klein A., Uzu S., Griebel D., Mulberg A. E., International Inflammatory Bowel Disease Working Group, 'Steps toward harmonization for clinical development of medicines in pediatric ulcerative colitis-a global scientific discussion, part 1: efficacy endpoints and disease outcome assessments', J Pediatr Gastroenterol Nutr, Vol. 58(6), pp. 679-683.
Tsigkos S., Llinares J., Mariz S., Aarum S., Fregonese L., Dembowska-Baginska B., Elbers R., Evers P., Foltanova T., Lhoir A., Corrêa-Nunes A., O'Connor D., Voordouw A., Westermark K., Sepodes B., 'Use of biomarkers in the context of orphan medicines designation in the European Union', Orphanet J Rare Dis, Vol. 9(1), 13.
Tsigkos S., Mariz S., Llinares J., Fregonese L., Aarum S., Naumann-Winter F., Westermark K., Sepodes B., 'Establishing medical plausibility in the context of orphan medicines designation in the European Union', Orphanet Journal of Rare Diseases, Vol. 9: 175.
The Expert Panel on Therapeutic Products for Infants, Children, and Youth, 'Improving Medicines for Children in Canada', the Council of Canadian Academies.
van Aerts L. A., De Smet K., Reichmann G., Willem van der Laan J., Schneider C. K., 'Biosimilars entering the clinic without animal studies: A paradigm shift in the European Union', MAbs 6(5), pp. 1155-1162.
van Riet-Nales D. A., Römkens E. G., Saint-Raymond A., Kozarewicz P., Schobben A. F., Egberts T. C., Rademaker C. M., 'Oral medicines for children in the European paediatric investigation plans', PLoS One., Vol. 9(6), p. e98348
Vetter T., GFR Decline as an End Point for Clinical Trials in CKD: A View From Europe, Am J Kidney Dis, Vol. 64(6), pp. 838-840.


Back to top

Baird L. G., Trusheim M. R., Eichler H. G., Berndt E. R., Hirsch G., 'Comparison of stakeholder metrics for traditional and adaptive development and licensing approaches to drug development', Therapeutic Innovation & Regulatory Science, Vol. 47(4), pp. 474-483.
Barkholt L., Flory E., Jekerle V., Lucas-Samuel S., Ahnert P., Bisset L., Büscher D., Fibbe W., Foussat A., Kwa M., Lantz O., Mačiulaitis R., Palomäki T., Schneider C. K., Sensebé L., Tachdjian G., Tarte K., Tosca L., Salmikangas P., 'Risk of tumorigenicity in mesenchymal stromal cell-based therapies - bridging scientific observations and regulatory viewpoints', Cytotherapy, Vol. 15(7), pp. 753-759.
Berntgen M., Enzmann H., Schabel E., Prieto Yerro C., Gómez-Outes A., Salmonson T., Musaus J., 'Linaclotide for treatment of irritable bowel syndrome - the view of European regulators', Dig Liver Dis, Vol. 45(9), pp. 724–726.
Berrut G., Andrieu S., Araujo de Carvalho I., Baeyens J. P., Bergman H., Cassim B., Cerreta F., Cesari M., Cha H. B., Chen L. K., Cherubini A., Chou M. Y., Cruz-Jentoft A. J., De Decker L., Du P., Forette B., Forette F., Franco A., Guimaraes R., Guttierrez-Robledo L. M., Jauregui J., Khavinson V., Lee W. J., Peng L. N., Perret-Guillaume C., Petrovic M., Retornaz F., Rockwood K., Rodriguez-Manas L., Sieber C., Spatharakis G., Theou O., Topinkova E., Vellas B., Benetos A., 'Promoting access to innovation for frail old persons. IAGG (International Association of Gerontology and Geriatrics), WHO (World Health Organization) and SFGG (Société Française de Gériatrie et de Gérontologie) Workshop - Athens January 20-21, 2012 Tool (GFST)', J Nutr Health Aging, Vol. 17(8), pp. 688-693.
Beyer A. R., Fasolo B., Phillips L. D., de Graeff P. A., Hillege H. L., 'Risk perception of prescription drugs: results of a survey among experts in the European regulatory network', Med Decis Making, Vol. 33(4), pp. 579-592.
Brassart, L., Skarlatos A., Papaluca M., Camanas Saez L., Cerreta F., 'Product information and older people: how to assist informed prescription and safe therapeutic use?', Regulatory Rapporteur, Vol. 10(7/8).
Breckenridge A., Eichler H. G., 'Towards a prevention model of health care', Nat Rev Drug Discov, Vol. 2(8), pp. 563-564.
Butlen-Ducuing F., Guelfi J. D., 'Méthodes d'étude chez l'homme', in: Les antidépresseurs, Lavoisier, January 2013.
Callréus T., Schneider C. K., 'The emergence of regulatory science in pharmaceutical medicine', Pharm Med, Vol. 27(6), pp. 345-351.
da Rocha Dias S., Salmonson T., van Zwieten-Boot B., Jonsson B., Marchetti S., Schellens J. H., Giuliani R., Pignatti F., 'The European Medicines Agency review of vemurafenib (Zelboraf®) for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma: summary of the scientific assessment of the Committee for Medicinal Products for Human Use', Eur J Cancer, Vol. 49(7), pp. 1654-1661.
Egger G. F., Herold R., Rodriguez A., Manent N., Sweeney F., Saint-Raymond A., 'European Union Clinical Trials Register: on the way to more transparency of clinical trial data', Expert Rev Clin Pharmacol, Vol. 6(5), pp. 457-459.
Ehmann F., Papaluca Amati M., Salmonson T., Posch M., Vamvakas S., Hemmings R., Eichler H. G., Schneider C. K., 'Gatekeepers and enablers: how drug regulators respond to a challenging and changing environment by moving toward a proactive attitude', Clin Pharmacol Ther, Vol. 93(5), pp. 425–432.
Ehmann F., Sakai-Kato K., Duncan R., Hernán Pérez de la Ossa D., Pita R., Vidal J. M., Kohli A., Tothfalusi L., Sanh A., Tinton S., Robert J. L., Silva Lima B., Papaluca Amati M., 'Next-generation nanomedicines and nanosimilars: EU regulators' initiatives relating to the development and evaluation of nanomedicines', Nanomedicine (Lond), Vol. 8(5), pp. 849-856.
Eichler H. G., Bloechl-Daum B., Brasseur D., Breckenridge A., Leufkens H., Raine J., Salmonson T., Schneider C. K., Rasi G., 'The risks of risk aversion in drug regulation', Nat Rev Drug Discov, Vol. 12(12), pp. 907-916.
Eichler H. G., Pétavy F., Pignatti F., Rasi G. 'Access to patient-level trial data - a boon to drug developers', N Engl J Med, Vol. 369(17), pp. 1577-1579.
Elmgren L., Li X., Wilson C., Ball R., Wang J., Cichutek K., Pfleiderer M., Kato A., Cavaleri M., Southern J., Jivapaisarnpong T., Minor P., Griffiths E., Sohn Y., Wood D., 'A global regulatory science agenda for vaccines', Vaccine, Vol. 31 Suppl 2, pp. B163-B175.
Franco P., 'Orphan drugs: the regulatory environment', Drug Discov Today, Vol. 18(3-4), pp. 163-172.
Gravanis I., 'Geriatric oncology: European Union regulatory perspectives and initiatives', J Geriatr Oncol, Vol. 4(2), pp. 202-204.
Gravanis I., Lopez A. S., Hemmings R. J., Jiménez J. C., Garcia-Carbonero R., Gallego I. G., Giménez E. V., O'Connor D., Giuliani R., Salmonson T., Pignatti F., 'The European Medicines Agency review of abiraterone for the treatment of metastatic castration-resistant prostate cancer in adult men after docetaxel chemotherapy and in chemotherapy-naive disease: summary of the scientific assessment of the Committee for Medicinal Products for Human Use', Oncologist, Vol. 18(9), pp. 1032-1042.
Henshall C., Sansom L., Eichler H.-G., Lemgruber A., Longson C., O'Rourke B., Tunis S., 'Understanding the role and evidence expectations of health technology assessment and coverage/payer bodies. What are they looking for, and how and why does this differ from what regulators require?', Therapeutic Innovation & Regulatory Science, 28 November 2013.
Hilger A., Arras-Reiter C., Keller-Stanislawski B., Ljungberg B., Male C., Mentzer D., Seitz R., Silvester G., 'Comment on: Mannucci, P. M. Evolution of the European guidelines for the clinical development of factor VIII products', Haemophilia, Vol. 19(3), pp. 349-350.
Janssens E., 'Pharmaceuticals: EU initiative to tackle medication errors – Proposals and challenges', Eur J Risk Regulation, Vol. 3/2013, pp. 388-391.
Karres J., Tomasi P., 'New medicines for type 2 diabetes in adolescents: many products, few patients', Expert Rev Clin Pharmacol, Vol. 6(3), pp. 227-229.
Köhne C. H., Bedenne L., Carrato A., Bouché O., Popov I., Gaspà L., Valladares M., Rougier P., Gog C., Reichardt P., Wils J., Pignatti F., Biertz F., 'A randomised phase III intergroup trial comparing high-dose infusional 5-fluorouracil with or without folinic acid with standard bolus 5-fluorouracil/folinic acid in the adjuvant treatment of stage III colon cancer: the Pan-European Trial in Adjuvant Colon Cancer 2 study', Eur J Cancer, Vol. 49(8), pp. 1868-1875.
Liberti L., McAuslane N., Patel P., Breckenridge A., Eichler H. G., Peterson R., 'Regulatory review: How do agencies ensure the quality of decision making?', Clin Pharmacol Ther, Vol. 94(3), pp. 305-308.
Lionetti G., Kimura Y., Schanberg L. E., Beukelman T., Wallace C. A., Ilowite N. T., Winsor J., Fox K., Natter M., Sundy J. S., Brodsky E., Curtis J. R., Del Gaizo V., Iyasu S., Jahreis A., Meeker-O'Connell A., Mittleman B. B., Murphy B. M., Peterson E. D., Raymond S. C., Setoguchi S., Siegel J. N., Sobel R. E., Solomon D., Southwood T. R., Vesely R., White P. H., Wulffraat N. M., Sandborg C. I., 'Using registries to identify adverse events in rheumatic diseases', Pediatrics, Vol. 132(5), e1384-e1394.
Maignen F., Hauben M., Hung E., Holle L. V., Dogne J. M., 'A conceptual approach to the masking effect of measures of disproportionality', Pharmacoepidemiol Drug Saf, Vol. 23(2), pp. 208-217.
Maignen F., Hauben M., Hung E., Van Holle L., Dogne J. M., 'Assessing the extent and impact of the masking effect of disproportionality analyses on two spontaneous reporting systems databases', Pharmacoepidemiol Drug Saf, Vol. 23(2), pp. 195-207.
Maliepaard M., Nofziger C., Papaluca M., Zineh I., Uyama Y., Prasad K., Grimstein C., Pacanowski M., Ehmann F., Dossena S., Paulmichl M., 'Pharmacogenetics in the evaluation of new drugs: a multiregional regulatory perspective', Nat Rev Drug Discov, Vol. 12(2), pp. 103-115.
Manolis E., Rohou S., Hemmings R., Salmonson T., Karlsson M., Milligan P. A.. 'The role of modeling and simulation in development and registration of medicinal products: Output from the EFPIA / EMA Modeling and Simulation Workshop', CPT Pharmacometrics Syst Pharmacol, Vol. 2, e31.
Marshall S. F., Hemmings R., Josephson F., Karlsson M. O., Posch M., Steimer J. L., 'Modeling and simulation to optimize the design and analysis of confirmatory trials, characterize risk-benefit, and support label claims', CPT Pharmacometrics Syst Pharmacol, Vol. 2, e27.
Melchiorri D., Pani L., Gasparini P., Cossu G., Ancans J., Borg J. J., Drai C., Fiedor P., Flory E., Hudson I., Leufkens H. G., Müller-Berghaus J., Narayanan G., Neugebauer B., Pokrotnieks J., Robert J. L., Salmonson T., Schneider C. K., 'Regulatory evaluation of Glybera in Europe - two committees, one mission', Nat Rev Drug Discov, Vol. 12(9), p. 719.
Péan E., Flores B., Hudson I., Sjöberg J., Dunder K., Salmonson T., Gisselbrecht C., Laane E., Pignatti F., 'The European Medicines Agency review of pixantrone for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin's B-cell lymphomas: summary of the scientific assessment of the Committee for Medicinal Products for Human Use', Oncologist, Vol. 18(5), pp. 625-633.
Phillips L. D., Fasolo B., Zafiropoulous N., Eichler H. G., Ehmann F., Jekerle V., Kramarz P., Nicoll A., Lönngren T., 'Modelling the risk-benefit impact of H1N1 influenza vaccines', Eur J Public Health, Vol. 23(4), pp. 674-678.
Putzeist M., Mantel-Teeuwisse A. K., Llinares J., Gispen-De Wied C. C., Hoes A. W., Leufkens H. G., 'EU marketing authorization review of orphan and non-orphan drugs does not differ', Drug Discov Today, Vol. 18(19–20), pp. 1001–1006.
Ruperto N., Vesely R., Saint-Raymond A., Martini A., 'Impact of the European paediatric legislation in paediatric rheumatology: past, present and future', Ann Rheum Dis, Vol. 72(12), pp.1893-1896.
Schneider C. K., 'The ethics of biosimilars', GaBI J, Vol. 2(1), pp. 6-7.
Slattery J., Alvarez Y., Hidalgo A., 'Choosing thresholds for statistical signal detection with the proportional reporting ratio', Drug Saf, Vol. 36(8), pp. 687-692.
Staab A., Rook E., Maliepaard M., Aarons L., Benson C., 'Modeling and simulation in clinical pharmacology and dose finding', CPT Pharmacometrics Syst Pharmacol, Vol. 2, e29.
Stephenson D., Aviles E., Bain L. J., Brumfield M., Carrillo M., Comery T. A., Compton C., Corrigan B., Forrest Gordon M., Jack C. R., Katz R., Logovinsky V., Satlin A., Marek K., Nicholas T., Polhamus D., Angersbach B. S., Raghavan N., Romano G., Romero K., Shaw L., Woodcock J., Vradenburg G., Isaac M., 'Coalition Against Major Diseases:
precompetitive collaborations and regulatory paths to accelerating drug development for neurodegenerative diseases
', Therapeutic Innovation & Regulatory Science, Vol. 47(6), pp. 632-638.
Tomasi P., 'Paediatric clinical trials: need for capacity building', J Clin Stud, Vol. 5(3), pp. 10-16.
Tomasi P., Saint-Raymond A., 'Scope of the PIP in the EU: easier accessibility to the paediatric rewards and simplification of administrative requirements', Scrip Regulatory Affairs, January 2013, p. 5.
Tzogani K., Straube M., Hoppe U., Kiely P., O'Dea G., Enzmann H., Salmon P., Salmonson T., Pignatti F., 'The European Medicines Agency approval of 5-aminolaevulinic acid (Ameluz) for the treatment of actinic keratosis of mild to moderate intensity on the face and scalp: Summary of the scientific assessment of the Committee for Medicinal Products for Human Use', J Dermatolog Treat, Vol. 25(5), pp. 371-374.
van Riet Nales D. A., Kozarewicz P., Wang S., Saint-Raymond A., Robert J. L., 'Comments on the EMA draft guideline: final steps towards a harmonized view between regulators and industry', Int J Pharm, Vol. 457(1), pp. 337-339.
Vaquer G., Rivière F., Mavris M., Bignami F., Llinares-Garcia J., Westermark K., Sepodes B., 'Animal models for metabolic, neuromuscular and ophthalmological rare diseases', Nat Rev Drug Discov, Vol. 12(4), pp. 287-305.
Vermeer N. S., Straus S. M., Mantel-Teeuwisse A. K., Domergue F., Egberts T. C., Leufkens H. G., De Bruin M. L., 'Traceability of biopharmaceuticals in spontaneous reporting systems: a cross-sectional study in the FDA Adverse Event Reporting System (FAERS) and EudraVigilance databases', Drug Saf, Vol. 36(8), pp. 617-625.
Vestergaard H. T., D'Apote L., Schneider C. K., Herberts C., 'The evolution of nonclinical regulatory science: advanced therapy medicinal products as a paradigm', Mol Ther, Vol. 21(9), pp. 1644-1648.
Vidal J. M., 'Non-clinical science and regulatory approach. An introduction', Toxicologische Communicatie, Data en Documentatie, Vol. 3, pp. 14-15.
Visser S. A., Manolis E., Danhof M., Kerbusch T., 'Modeling and simulation at the interface of nonclinical and early clinical drug development', CPT Pharmacometrics Syst Pharmacol, Vol. 2, e30.


Back to top

Bahri P., Harrison-Woolrych M., 'Focusing on risk communication about medicines: why now?', Drug Saf, Vol. 35(11), pp. 971-975.
Bahri P., Harrison-Woolrych M., 'How to improve communication for the safe use of medicines? Discussions on social marketing and patient-tailored approaches at the annual meetings of the WHO Programme for International Drug Monitoring', Drug Saf, Vol. 35(12), pp. 1073-1079.
Blake K. V., Devries C. S., Arlett P., Kurz X., Fitt H., 'Increasing scientific standards, independence and transparency in post-authorisation studies: the role of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance', Pharmacoepidemiol Drug Saf, Vol. 21(7), pp. 690-696.
Butlen-Ducuing F., Haas M., Pani L., van Zwieten-Boot B., Broich K., 'DSM-5 and clinical trials in psychiatry: challenges to come?', Nat Rev Drug Discov, Vol. 11(8), pp. 583-584.
Calderon M. A., Gerth van Wijk R., Eichler I., Matricardi P. M., Varga E. M., Kopp M. V., Eng P., Niggemann B., Nieto A., Valovirta E., Eigenmann P. A., Pajno G., Bufe A., Halken S., Beyer K., Wahn U., European Academy of Allergy and Clinical Immunology, 'Perspectives on allergen-specific immunotherapy in childhood: an EAACI position statement', Pediatr Allergy Immunol, Vol. 23(4), pp. 300-306.
Cerreta F., Eichler H. G., Rasi G., 'Drug policy for an aging population — the European Medicines Agency's geriatric medicines strategy', N Engl J Med, Vol. 367(21), pp. 1972-1974.
Cesari M., Fielding R. A., Pahor M., Goodpaster B., Hellerstein M., van Kan G. A., Anker S. D., Rutkove S., Vrijbloed J. W., Isaac M., Rolland Y., M'rini C., Aubertin-Leheudre M., Cedarbaum J. M., Zamboni M., Sieber C. C., Laurent D., Evans W. J., Roubenoff R., Morley J. E., Vellas B., International Working Group on Sarcopenia, 'Biomarkers of sarcopenia in clinical trials-recommendations from the International Working Group on Sarcopenia', J Cachexia Sarcopenia Muscle, Vol. 3(3), pp. 181-190.
Eichler H. G., Abadie E., Baker M., Rasi G., 'Fifty years after thalidomide; what role for drug regulators?', Br J Clin Pharmacol, Vol. 74(5), pp. 731-733.
Eichler H. G., Abadie E., Breckenridge A., Leufkens H., Rasi G., 'Open clinical trial data for all? A view from regulators', PLoS Med, Vol. 9(4), e1001202.
Eichler H. G., Oye K., Baird L. G., Abadie E., Brown J., Drum C. L., Ferguson J., Garner S., Honig P., Hukkelhoven M., Lim J. C., Lim R., Lumpkin M. M., Neil G., O'Rourke B., Pezalla E., Shoda D., Seyfert-Margolis V., Sigal E. V., Sobotka J., Tan D., Unger T. F., Hirsch G., 'Adaptive licensing: taking the next step in the evolution of drug approval', Clin Pharmacol Ther, Vol. 91(3), pp. 426-437.
Gaydos B., Koch A., Miller F., Posch M., Vandemeulebroecke M., Wang S.-J., 'Perspective on adaptive designs: 4 years European Medicines Agency reflection paper, 1 year draft US FDA guidance – where are we now?', Clin Invest, Vol. 2(3), pp. 235-240.
Gispen-de Wied C., Stoyanova V., Yu Y., Isaac M., Pani L., de Andres-Trelles F., 'The placebo arm in clinical studies for treatment of psychiatric disorders: a regulatory dilemma', Eur Neuropsychopharmacol, Vol. 22(11), pp. 804-811.
Grave K., Greko C., Kvaale M. K., Torren-Edo J., Mackay D., Muller A., Moulin G., ESVAC Group, 'Sales of veterinary antibacterial agents in nine European countries during 2005-09: trends and patterns', J Antimicrob Chemother, Vol. 67(12), pp. 3001-3008.
Grein K., 'Responsibilities of regulatory agencies in the marketing of antimicrobials', Rev Sci Tech, Vol. 31(1), pp. 289-298.
Hidalgo-Simon A., Arlett P., 'Pharmacovigilance in Europe: direction of travel in a changing environment', Expert Rev Clin Pharmacol, Vol. 5(5), pp. 485-488.
Isaac M., Pani L., Gispen-de Wied C., Koch A., 'European licensing of maintenance treatment in schizophrenia', Lancet, Vol. 380(9841), pp. 562-563.
Isai A., Durand J., Le Meur S., Hidalgo-Simon A., Kurz X., 'Autoimmune disorders after immunisation with Influenza A/H1N1 vaccines with and without adjuvant: EudraVigilance data and literature review', Vaccine, Vol. 30(49), pp. 7123-7129.
Klug B., Celis P., Carr M., Reinhardt J., 'Regulatory structures for gene therapy medicinal products in the European Union', In: Freeman T. (ed.), Gene transfer vectors for clinical application, United Kingdom, Academic Press, pp. 337-354.
Lumpkin M. M., Eichler H. G., Breckenridge A., Hamburg M. A., Lönngren T., Woods K., 'Advancing the science of medicines regulation: the role of the 21st-century medicines regulator', Clin Pharmacol Ther, Vol. 92(4), pp. 486-493.
Maciulaitis R., D'Apote L., Buchanan A., Pioppo L., Schneider C. K., 'Clinical development of advanced therapy medicinal products in Europe: evidence that regulators must be proactive', Mol Ther, 20(3), pp. 479-482.
Maxwell S., Eichler H. G., Bucsics A., Haefeli W. E., Gustafsson L. L., e-SPC Consortium, 'e-SPC - delivering drug information in the 21st century: developing new approaches to deliver drug information to prescribers', Br J Clin Pharmacol, Vol. 73(1), pp. 12-15.
Mischak H., Ioannidis J. P., Argiles A., Attwood T. K., Bongcam-Rudloff E., Broenstrup M., Charonis A., Chrousos G. P., Delles C., Dominiczak A., Dylag T., Ehrich J., Egido J., Findeisen P., Jankowski J., Johnson R. W., Julien B. A., Lankisch T., Leung H. Y., Maahs D., Magni F., Manns M. P., Manolis E., Mayer G., Navis G., Novak J., Ortiz A., Persson F., Peter K., Riese H. H., Rossing P., Sattar N., Spasovski G., Thongboonkerd V., Vanholder R., Schanstra J. P., Vlahou A., 'Implementation of proteomic biomarkers: making it work', Eur J Clin Invest, Vol. 42(9), pp. 1027-1036.
Mullier F., Rahier J. F., Maignen F., Cornet Y., Graux C., Chatelain C., Chatelain B., Dogne J. M., 'A case of therapy-related myeloid neoplasm in a patient with Crohn's disease treated with azathioprine', Acta Haematol, Vol. 128(1), pp. 1-6.
Pean E., Demolis P., Moreau A., Hemmings R. J., O'Connor D., Brown D., Shepard T., Abadie E., Pignatti F., 'The European Medicines Agency review of cabazitaxel (Jevtana®) for the treatment of hormone-refractory metastatic prostate cancer: summary of the scientific assessment of the Committee for Medicinal Products for Human Use', Oncologist, Vol. 17(4), pp. 543-549.
Pean E., Klaar S., Berglund E. G., Salmonson T., Borregaard J., Hofland K. F., Ersbøll J., Abadie E., Giuliani R., Pignatti F., 'The European Medicines Agency review of eribulin for the treatment of patients with locally advanced or metastatic breast cancer: summary of the scientific assessment of the Committee for Medicinal Products for Human Use', Clin Cancer Res, Vol. 18(17), pp. 4491-4497.
Pelkonen O., Abass K., Wiesner J., 'Thujone and thujone-containing herbal medicinal and botanical products: toxicological assessment', Regul Toxicol Pharmacol, Vol. 65(1), pp. 100-107.
Pignatti F., Flores B., Jonsson B., 'Platelet response as the basis for approval in chronic immune (idiopathic) thrombocytopenic purpura (ITP): a regulatory perspective', Am J Hematol, Vol. 87, pp. 943-944.
Posch M., Proschan M. A., 'Unplanned adaptations before breaking the blind', Stat Med, Vol. 31(30), pp. 4146-4153.
Prieto L., Spooner A., Hidalgo-Simon A., Rubino A., Kurz X., Arlett P., 'Evaluation of the effectiveness of risk minimization measures', Pharmacoepidemiol Drug Saf, Vol. 21(8), pp. 896-899.
Putzeist M., Mantel-Teeuwisse A. K., Aronsson B., Rowland M., Gispen-de Wied C. C., Vamvakas S., Hoes A. W., Leufkens H. G., Eichler H. G., 'Factors influencing non-approval of new drugs in Europe', Nat Rev Drug Discov, Vol. 11(12), pp. 903-904.
Quigley K., 'Veterinary medicines: What is the MUMS / limited markets policy?', Regulatory Rapporteur, Vol. 10(2).
Saint-Raymond A., Herold R., 'Medicines for pediatric oncology: can we overcome the failure to deliver?', Expert Rev Clin Pharmacol, Vol. 5(5), pp. 493-495.
Sala Soriano E., Eichler I., Helms P. J., 'Joined-up thinking', European Pharmaceutical Contractor, March 2012, pp. 35-36.
Schneider C. K., Vleminckx C., Gravanis I., Ehmann F., Trouvin J. H., Weise M., Thirstrup S., 'Setting the stage for biosimilar monoclonal antibodies', Nat Biotechnol, Vol. 30(12), pp. 1179-1185.
Stegemann S., Baeyens J.-P., Cerreta F., Chanied E., Löfgren A., Maio M., Schreier G., Thesing-Bleck E., 'Adherence measurement systems and technology for medications in older patient populations', Eur Geriatr Med, Vol. 3(4), pp. 254-260.
Tomasi P., 'Writing applications for paediatric investigation plans and waivers', Medical Writing, Vol. 21(2), pp. 104-107.
van Riet-Nales D. A., Wang S., Saint-Raymond A., Robert J. L., 'The EMA quality guideline on the pharmaceutical development of medicines for paediatric use', Int J Pharm, Vol. 435(2), pp. 132-134.
Veselý R., Haf Davies E., 'Helping the medicine go down', Public Service Review: European Science & Technology, Vol. 14, pp. 1-2.
Videnova K., Mackay D. K., 'Availability of vaccines against major animal diseases in the European Union', Rev Sci Tech, Vol. 31(3), pp. 971-978.
Vinhas de Souza M., Keller-Stanislawski B., Blake K., Hidalgo-Simon A., Arlett P., Dal Pan G., 'Drug-induced PML: a global agenda for a global challenge', Clin Pharmacol Ther, Vol. 91(4), pp. 747-750.
Westermark K., Llinares J., 'Promoting the development of drugs against rare diseases: what more should be done?', Expert Rev Pharmacoecon Outcomes Res, Vol. 12(5), pp. 541-543.
Zafiropoulos N., Phillips L., Pignatti F., Luria X., 'Evaluating benefit–risk: an Agency perspective', Regulatory Rapporteur, Vol. 9(6), pp. 5-8.
Zehetmayer S., Posch M., 'False discovery rate control in two-stage designs', BMC Bioinformatics, Vol. 13, 81.
Zomerdijk I. M., Sayed-Tabatabaei F. A., Trifirò G., Blackburn S. C., Sturkenboom M. C., Straus S. M., 'Risk minimization activities of centrally authorized products in the EU: a descriptive study', Drug Saf, Vol. 35(4), pp. 299-314.


Back to top

Arlett P.R., Kurz X., 'New approaches to strengthen pharmacovigilance', Drug Discov Today Technol, Vol. 8(1), e15–e19.
Arnardottir A. H., Haaijer-Ruskamp F. M., Straus S. M., Eichler H. G., de Graeff P. A., Mol P. G., 'Additional safety risk to exceptionally approved drugs in Europe?', Br J Clin Pharmacol, Vol. 72(3), pp. 490-499.
Bahri P., Mol P. G., Théophile H., Edwards I. R., Hugman B. P., 'Communication in drug safety: a report from an interactive debate held at the 10th annual meeting of the International Society of Pharmacovigilance (ISoP), 2010', Drug Saf, Vol. 34(10), pp. 881-882.
Blake K. V., Prilla S., Accadebled S., Guimier M., Biscaro M., Persson I., Arlett P., Blackburn S., Fitt H., 'European Medicines Agency review of post-authorisation studies with implications for the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance', Pharmacoepidemiol Drug Saf, Vol. 20(10), pp. 1021-1029.
Blake K. V., Smeraldi C., Kurz X., Arlett P., Blackburn S., Fitt H., 'The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance: application to diabetes and vascular disease', British Journal of Diabetes & Vascular Disease, Vol. 11(6), pp. 304-307.
Büttel I. C., Chamberlain P., Chowers Y., Ehmann F., Greinacher A., Jefferis R., Kramer D., Kropshofer H., Lloyd P., Lubiniecki A., Krause R., Mire-Sluis A., Platts-Mills T., Ragheb J. A., Reipert B. M., Schellekens H., Seitz R., Stas P., Subramanyam M., Thorpe R., Trouvin J. H., Weise M., Windisch J., Schneider C. K., 'Taking immunogenicity assessment of therapeutic proteins to the next level', Biologicals, Vol. 39(2), pp. 100-109.
Carleer J., Karres J., 'Juvenile animal studies and pediatric drug development: a European regulatory perspective', Birth Defects Res B Dev Reprod Toxicol, Vol. 92(4), pp. 254-260.
De Mattia F., Chapsal J. M., Descamps J., Halder M., Jarrett N., Kross I., Mortiaux F., Ponsar C., Redhead K., McKelvie J., Hendriksen C., 'The consistency approach for quality control of vaccines - a strategy to improve quality control and implement 3Rs', Biologicals, Vol. 39(1), pp. 59-65.
Ehmann F., Schneider C. K., 'Biosimilar monoclonal antibodies: The implications', Hospital Pharmacy Europe, Vol. 56, May/June 2011.
Eichler H. G., Abadie E., Breckenridge A., Flamion B., Gustafsson L. L., Leufkens H., Rowland M., Schneider C. K., Bloechl-Daum B., 'Bridging the efficacy-effectiveness gap: a regulator's perspective on addressing variability of drug response', Nat Rev Drug Discov, Vol. 10(7), pp. 495-506.
Eichler I., Soriano E. S., 'Close collaboration between academia, industry and drug regulators is required in the development of allergen products for specific immunotherapy in children', Allergy, Vol. 66(8), pp. 999-1004.
Freire-Moran L., Aronsson B., Manz C., Gyssens I. C., So A. D., Monnet D. L., Cars O., ECDC-EMA Working Group, 'Critical shortage of new antibiotics in development against multidrug-resistant bacteria - time to react is now', Drug Resist Updat, Vol. 14(2), pp. 118-124.
Hanaizi Z., van Zwieten-Boot B., Calvo G., Lopez A. S., van Dartel M., Camarero J., Abadie E., Pignatti F., 'The European Medicines Agency review of ipilimumab (Yervoy) for the treatment of advanced (unresectable or metastatic) melanoma in adults who have received prior therapy: summary of the scientific assessment of the Committee for Medicinal Products for Human Use', Eur J Cancer, Vol. 48, pp. 237-242.
Hatzakis A., Wait S., Bruix J., Buti M., Carballo M., Cavaleri M., Colombo M., Delarocque-Astagneau E., Dusheiko G., Esmat G., Esteban R., Goldberg D., Gore C., Lok A. S., Manns M., Marcellin P., Papatheodoridis G., Peterle A., Prati D., Piorkowsky N., Rizzetto M., Roudot-Thoraval F., Soriano V., Thomas H. C., Thursz M., Valla D., van Damme P., Veldhuijzen I. K., Wedemeyer H., Wiessing L., Zanetti A. R., Janssen H. L., 'The state of hepatitis B and C in Europe: report from the hepatitis B and C summit conference', J Viral Hepat, Vol. 18 Suppl 1, pp. 1-16.
Heininger U., Bachtiar N. S., Bahri P., Dana A., Dodoo A., Gidudu J., Santos E. M., 'The concept of vaccination failure', Vaccine, Vol. 30(7), pp. 1265-1268.
Isaac M., Vamvakas S., Abadie E., Jonsson B., Gispen C., Pani L., 'Qualification opinion of novel methodologies in the predementia stage of Alzheimer's disease: cerebro-spinal-fluid related biomarkers for drugs affecting amyloid burden - regulatory considerations by European Medicines Agency focusing in improving benefit', Eur Neuropsychopharmacol, Vol. 21(11), pp. 781-788.
Karres J., Tomasi P., Saint-Raymond A., 'The development of pharmacological treatment of obesity in children. A European regulatory perspective', Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz, Vol. 54(5), pp. 570-576.
Korakianiti E., Rekkas D., 'Statistical thinking and knowledge management for quality-driven design and manufacturing in pharmaceuticals', Pharm Res, Vol. 28(7), pp. 1465-1479.
Kurz X., Domergue F., Slattery J., Segec A., Szmigiel A., Hidalgo-Simon A., 'Safety monitoring of influenza A/H1N1 pandemic vaccines in EudraVigilance', Vaccine, Vol. 29(26), pp. 4378-4387.
Leufkens H. G., Eichler H. G., 'Innovative methods in drug regulatory sciences', Drug Discov Today Technol, Vol. 8(1), e1-e2.
Leufkens H. G., Schellekens H., Aronsson B., 'Post-innovation innovation of medicinal products', Drug Discov Today Technol, Vol. 8(1), e37-e41.
Manolis E., Herold R., 'Pharmacometrics for regulatory decision making: status and perspective', Clin Pharmacokinet, Vol. 50(10), pp. 625-626.
Manolis E., Osman T. E., Herold R., Koenig F., Tomasi P., Vamvakas S., Saint-Raymond A., 'Role of modeling and simulation in pediatric investigation plans', Paediatr Anaesth, Vol. 21(3), pp. 214-221.
Manolis E., Vamvakas S., Isaac M., 'New pathway for qualification of novel methodologies in the European Medicines Agency', Proteomics Clin Appl, Vol. 5(5-6), pp. 248-255.
Mariz S., Llinares J., Westermark K., 'Orphan drugs. EU regulations', BMJ, Vol. 342, d136.
Matt P., van Zwieten-Boot B., Calvo Rojas G., Ter Hofstede H., Garcia-Carbonero R., Camarero J., Abadie E., Pignatti F, 'The European Medicines Agency review of tegafur / gimeracil / oteracil (Teysuno™) for the treatment of advanced gastric cancer when given in combination with cisplatin: summary of the scientific assessment of the Committee for Medicinal Products for Human Use', Oncologist, Vol. 16(10), pp. 1451-1457.
Müllner M., Eichler H.-G., 'Current issues in drug regulation', In: M. Müllner (ed.), Clinical Pharmacology: Current Topics and Case Studies, Springer Vienna, pp. 19-31.
Nieto M., Borregaard J., Ersbøll J., ten Bosch G. J., van Zwieten-Boot B., Abadie E., Schellens J. H., Pignatti F., 'The European Medicines Agency review of pazopanib for the treatment of advanced renal cell carcinoma: summary of the scientific assessment of the Committee for Medicinal Products for Human Use', Clin Cancer Res, Vol. 17(21), pp. 6608-6614.
Nieto M., Calvo G., Hudson I., Feldschreiber P., Brown D., Lee C. C., Lay G., Valeri A., Abadie E., Thomas A., Pignatti F., 'The European Medicines Agency review of eltrombopag (Revolade) for the treatment of adult chronic immune (idiopathic) thrombocytopenic purpura: summary of the scientific assessment of the Committee for Medicinal Products for Human Use', Haematologica, Vol. 96(9), e33-e40.
Olski T. M., Lampus S. F., Gherarducci G., Saint Raymond A., 'Three years of paediatric regulation in the European Union', Eur J Clin Pharmacol, Vol. 67(3), pp. 245-252.
Phillips L. D., Fasolo B., Zafiropoulos N., Beyer A., 'Is quantitative benefit-risk modelling of drugs desirable or possible?' Drug Discov Today Technol, Vol. 8(1), e3–e10.
Pignatti F., Gravanis I., Herold R., Vamvakas S., Jonsson B., Marty M., 'The European Medicines Agency: an overview of its mission, responsibilities, and recent initiatives in cancer drug regulation', Clin Cancer Res, Vol. 17(16), pp. 5220-5225.
Pignatti F., Hemmings R., Jonsson B., 'Is it time to abandon complete blinded independent central radiological evaluation of progression in registration trials?', Eur J Cancer, Vol. 47(12), pp. 1759-1762.
Pignatti F., Luria X., Abadie E., Eichler H. G., 'Regulators, payers, and prescribers: can we fill the gaps?', Lancet Oncol, Vol. 12(10), pp. 930-931.
Pirmohamed M., Friedmann P. S., Molokhia M., Loke Y. K., Smith C., Phillips E., La Grenade L., Carleton B., Papaluca-Amati M., Demoly P., Shear N. H., 'Phenotype standardization for immune-mediated drug-induced skin injury', Clin Pharmacol Ther, Vol. 89(6), pp. 896-901.
Putzeist M., Heemstra H. E., Llinares Garcia J., Mantel-Teeuwisse A. K., Gispen-De Wied C. C., Hoes A. W., Leufkens H. G., 'Determinants for successful marketing authorisation of orphan medicinal products in the EU', Drug Discov Today, Vol. 17(7-8), pp. 352-358.
Rahmner P. B., Eiermann B., Korkmaz S., Gustafsson L. L., Gruvén M., Maxwell S., Eichler H. G., Vég A., 'Physicians' reported needs of drug information at point of care in Sweden', Br J Clin Pharmacol, Vol. 73(1), pp. 115-125.
Raine J., Wise L., Blackburn S., Eichler H. G., Breckenridge A., 'European perspective on risk management and drug safety', Clin Pharmacol Ther, Vol. 89(5), pp. 650-654.
Rocchi F., Tomasi P., 'The development of medicines for children', Pharmacol Res, Vol. 64(3), pp. 169-175.
Ruperto N., Eichler I., Herold R., Vassal G., Giaquinto C., Hjorth L., Valls-i-Soler A., Peters C., Helms P. J., Saint Raymond A., 'A European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA)', Arch Dis Child, Vol. 97(3), pp. 185-188.
Salmikangas P., Celis P., 'Current challenges in the development of novel cell-based medicinal products', Regulatory Rapporteur, Vol. 8(7-8), pp. 4-7.
Silva Lima B., 'EMA responds to criticism of reflection paper on non-clinical studies for generic nano-particle iron medicinal product applications', Scrip Regulatory Affairs, 12 August 2011.
Vamvakas S., Martinalbo J., Pita R., Isaac M., 'On the edge of new technologies (advanced therapies, nanomedicines)', Drug Discov Today Technol, Vol. 8(1), e21-e28.
Vleminckx C., Ehmann F., 'Guidelines EMA pour le développement de médicaments biosimilaires', Oncologie, Vol. 13(5), pp. 191-195.
Voltz-Girolt C., Celis P., Boucaumont M., D'Apote L., Pinheiro M. H., Papaluca-Amati M., 'The advanced therapy classification procedure. Overview of experience gained so far', Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz, Vol. 54(7), pp. 811-815.
Weise M., Bielsky M. C., De Smet K., Ehmann F., Ekman N., Narayanan G., Heim H. K., Heinonen E., Ho K., Thorpe R., Vleminckx C., Wadhwa M., Schneider C. K., 'Biosimilars - Why terminology matters', Nat Biotechnol, Vol. 29(8), pp. 690-693.
Westermark K., Holm B. B., Söderholm M., Llinares-Garcia J., Rivière F., Aarum S., Butlen-Ducuing F., Tsigkos S., Wilk-Kachlicka A., N'Diamoi C., Borvendég J., Lyons D., Sepodes B., Bloechl-Daum B., Lhoir A., Todorova M., Kkolos I., Kubáčková K., Bosch-Traberg H., Tillmann V., Saano V., Héron E., Elbers R., Siouti M., Eggenhofer J., Salmon P., Clementi M., Krieviņš D., Matulevičiene A., Metz H., Vincenti A. C., Voordouw A., Dembowska-Bagińska B., Nunes A. C., Saleh F. M., Foltánová T., Možina M., Torrent i Farnell J., Beerman B., Mariz S., Evers M. P., Greene L., Thorsteinsson S., Gramstad L., Mavris M., Bignami F., Lorence A., Belorgey C., 'European regulation on orphan medicinal products: 10 years of experience and future perspectives', Nat Rev Drug Discov, Vol. 10(5), pp. 341-349.

Wirth S., Kelly D., Sokal E., Socha P., Mieli-Vergani G., Dhawan A., Lacaille F., Saint-Raymond A., Olivier S., Taminiau J., 'Guidance for clinical trials for children and adolescents with chronic hepatitis C', J Pediatr Gastroenterol Nutr, Vol. 52(2), pp. 233-237.


Back to top

Alvarez Y., Hidalgo A., Maignen F., Slattery J., 'Validation of statistical signal detection procedures in EudraVigilance post-authorization data: a retrospective evaluation of the potential for earlier signalling', Drug Saf, Vol. 33(6), pp. 475-487.
Bahri P., 'Public pharmacovigilance communication: a process calling for evidence-based, objective-driven strategies', Drug Saf, Vol. 33(12), pp. 1065-1079.
Bauer P., Koenig F., Brannath W., Posch M., 'Selection and bias - two hostile brothers', Stat Med, Vol. 29(1), pp. 1-13.
Blind E., Dunder K., de Graeff P. A., Abadie E., 'Rosiglitazone: a European regulatory perspective', Diabetologia, Vol. 54(2), pp. 213-218.
Bloechl-Daum B., Butlen-Ducuing F., Llinares-Garcia J., 'Special situations, market fragmentation: orphan drugs for rare diseases' in: Clinical pharmacology: current topics and case studies, Vienna, New York, Springer.
Brosch S., Spina A., 'Pharmaceuticals: International Conference on Harmonisation and Standardisation initiatives in the pharmaceutical domain', Eur J Risk Regulation, Vol. 3, pp. 274-276.
Butlen-Ducuing F., Rivière F., Aarum S., Llinares-Garcia J., 'European Medicines Agency support mechanisms fostering orphan drug development', Drug News Perspect, Vol. 23(1), pp. 71-81.
Butlen-Ducuing F., Tsigkos S. 'Ten years of orphan drug designation in Europe', EHJP Practice, Vol. 16(4), pp. 19-20.
Davies E. H., Ollivier C. M., Saint-Raymond A., 'Paediatric investigation plans for pain: painfully slow!', Eur J Clin Pharmacol, Vol. 66(11), pp. 1091-1097.
Del Seppia I., 'Lost in translation': scientific names of medicine in a globalized world', Eur J Risk Regulation, Vol. 4, pp. 431-435.
Dieterle F., Sistare F., Goodsaid F., Papaluca M., Ozer J. S., Webb C. P., Baer W., Senagore A., Schipper M. J., Vonderscher J., Sultana S., Gerhold D. L., Phillips J. A., Maurer G., Carl K., Laurie D., Harpur E., Sonee M., Ennulat D., Holder D., Andrews-Cleavenger D., Gu Y. Z., Thompson K. L., Goering P. L., Vidal J. M., Abadie E., Maciulaitis R., Jacobson-Kram D., Defelice A. F., Hausner E. A., Blank M., Thompson A., Harlow P., Throckmorton D., Xiao S., Xu N., Taylor W., Vamvakas S., Flamion B., Lima B. S., Kasper P., Pasanen M., Prasad K., Troth S., Bounous D., Robinson-Gravatt D., Betton G., Davis M. A., Akunda J., McDuffie J. E., Suter L., Obert L., Guffroy M., Pinches M., Jayadev S., Blomme E. A., Beushausen S. A., Barlow V. G., Collins N., Waring J., Honor D., Snook S., Lee J., Rossi P., Walker E., Mattes W., 'Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium', Nat Biotechnol, Vol. 28(5), pp. 455–462.
Eichler H. G., Aronsson B., Abadie E., Salmonson T., 'New drug approval success rate in Europe in 2009', Nat Rev Drug Discov, Vol. 9(5), pp. 355-356.
Eichler H. G., Bloechl-Daum B., Abadie E., Barnett D., König F., Pearson S., 'Relative efficacy of drugs: an emerging issue between regulatory agencies and third-party payers', Nat Rev Drug Discov, Vol. 9(4), pp. 277-291.
Eichler H. G., Hemmings R. J., Vamvakas S., 'Where statisticians can contribute to address future challenges for drug regulatory agencies: a view from the European Medicines Agency (EMEA)', Stat Biopharm Res, Vol. 2(3), pp. 355-358.
Goodsaid F. M., Amur S., Aubrecht J., Burczynski M. E., Carl K., Catalano J., Charlab R., Close S., Cornu-Artis C., Essioux L., Fornace A. J. Jr, Hinman L., Hong H., Hunt I., Jacobson-Kram D., Jawaid A., Laurie D., Lesko L., Li H. H., Lindpaintner K., Mayne J., Morrow P., Papaluca-Amati M., Robison T. W., Roth J., Schuppe-Koistinen I., Shi L., Spleiss O., Tong W., Truter S. L., Vonderscher J., Westelinck A., Zhang L., Zineh I., 'Voluntary exploratory data submissions to the US FDA and the EMA: experience and impact', Nat Rev Drug Discov, Vol. 9(6), pp. 435-445.
Gravanis I., Ersbøll J., Skovlund E., Abadie E., Marty M., Pignatti F., 'The European Medicines Agency review of ofatumumab (Arzerra®) for the treatment of chronic lymphocytic leukemia in patients refractory to fludarabine and alemtuzumab: summary of the scientific assessment of the European Medicines Agency Committee for Medicinal Products for Human Use', Oncologist, Vol. 15(12), pp. 1335-1343.
Grave K., Torren Edo J., Mackay D., 'Comparison of the sales of veterinary antibacterial agents between 10 European countries', J Antimicrob Chemother, Vol. 65(9), pp. 2037-2040.
Herold R., Saint-Raymond A., 'Preamble may not improve consent and assent process', Ped Blood Cancer, Vol. 56(2), p. 327.
Isaac M., Koch A., 'The risk of death among adult participants in trials of antipsychotic drugs in schizophrenia', Eur Neuropsychopharmacol, Vol. 20(3), pp. 139-145.
Jablonski T., 'Pharmaceuticals: End of the transitional period for traditional herbal medicinal products coming soon', Eur J Risk Regulation, Vol. 2, pp. 156-159.
Liberti L., Breckenridge A., Eichler H. G., Peterson R., McAuslane N., Walker S., 'Expediting patients' access to medicines by improving the predictability of drug development and the regulatory approval process', Clin Pharmacol Ther, Vol. 87(1), 27-31.
Mackay D., Kriz N., 'Current challenges in viral safety and extraneous agent testing', Biologicals, Vol. 38(3), pp. 335-337.
Maignen F., Hauben M., Tsintis P., 'Modelling the time to onset of adverse reactions with parametric survival distributions: a potential approach to signal detection and evaluation', Drug Saf, Vol. 33(5), pp. 417-434.
Matheis K., Laurie D., Andriamandroso C., Arber N., Badimon L., Benain X., Bendjama K., Clavier I., Colman P., Firat H., Goepfert J., Hall S., Joos T., Kraus S., Kretschmer A., Merz M., Padro T., Planatscher H., Rossi A., Schneiderhan-Marra N., Schuppe-Koistinen I., Thomann P., Vidal J. M., Molac B., 'A generic operational strategy to qualify translational safety biomarkers', Drug Discov Today, Vol. 16(13-14), pp. 600-608.
Regnstrom J., Koenig F., Aronsson B., Reimer T., Svendsen K., Tsigkos S., Flamion B., Eichler H. G., Vamvakas S., 'Factors associated with success of market authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency', Eur J Clin Pharmacol, Vol. 66(1), pp. 39-48.
Saint-Raymond A., 'EMEA sees benefits for children', Applied Clinical Trials Online, February 2010.
Saint-Raymond A., 'Regulatory aspects of drug development in children: change and resistance to change', Expert Rev Clin Pharmacol, Vol. 3(5), pp. 593-595.
Saint-Raymond A., Hill S., Martines J., Bahl R., Fontaine O., Bero L., 'CONSORT 2010', Lancet, Vol. 376(9737), pp. 229-230.
Seigneuret N., 'The paediatric regulation: three years on', Regulatory Rapporteur, Vol. 7(6), pp. 5-9.
Silva-Lima B., Due Theilade-Thomsen M., Carleer J., Vidal J. M., Tomasi P., Saint-Raymond A., 'Juvenile animal studies for the development of paediatric medicines: a description and conclusions from a European Medicines Agency workshop on juvenile animal testing for nonclinical assessors', Birth Defects Res B Dev Reprod Toxicol, Vol. 89(6), pp. 467-473.
Sistare F. D., Dieterle F., Troth S., Holder D.J., Gerhold D., Andrews-Cleavenger D., Baer W., Betton G., Bounous D., Carl K., Collins N., Goering P., Goodsaid F., Gu Y. Z., Guilpin V., Harpur E., Hassan A., Jacobson-Kram D., Kasper P., Laurie D., Lima B. S., Maciulaitis R., Mattes W., Maurer G., Obert L. A., Ozer J., Papaluca-Amati M., Phillips J. A., Pinches M., Schipper M. J., Thompson K. L., Vamvakas S., Vidal J. M., Vonderscher J., Walker E., Webb C., Yu Y., 'Towards consensus practices to qualify safety biomarkers for use in early drug development', Nat Biotechnol, Vol. 28(5), pp. 446–454.
Spina A. 'European networks in the regulation of biotechnologies', Eur Law Rev, Vol. 35(2), pp. 197-213.
Stoyanova-Beninska V. V., Wohlfarth T,. Isaac M., Kalverdijk L. J., van den Berg H., Gispen-de Wied C., 'The EU paediatric regulation: effects on paediatric psychopharmacology in Europe', Eur Neuropsychopharmacol, Vol. 21(8), pp. 565-570.
Surh L. C., Pacanowski M. A., Haga S. B., Hobbs S., Lesko L. J., Gottlieb S., Papaluca-Amati M., Patterson S. D., Hughes A. R., Kim M. J., Close S. L., Mosteller M., Zineh I., Dechairo B., Cohen N. A., 'Learning from product labels and label changes: how to build pharmacogenomics into drug-development programs', Pharmacogenomics, Vol. 11(12), pp. 1637-1647.
Tomasi P., 'In search of safe and effective medicines', European Pharmaceutical Contractor, winter 2010, pp. 46-49.
Vidal J. M., Kawabata T. T., Thorpe R., Silva-Lima B., Cederbrant K., Poole S., Mueller-Berghaus J., Pallardy M., van der Laan J. W., 'In vitro cytokine release assays for predicting cytokine release syndrome: the current state-of-the-science. Report of a European Medicines Agency workshop', Cytokine, Vol. 51(2), pp. 213-215.


Back to top

Borg J. J., Robert J. L., Wade G., Aislaitner D., Pirożynski M., Abadie E., Salmonson T., Vella Bonanno P., 'Where is industry getting it wrong? A review of quality concerns raised at day 120 by the Committee for Medicinal Products for Human Use during European centralised marketing authorisation submissions for chemical entity medicinal products', J Pharm Pharm Sci, Vol. 12(2), pp. 181-198.
Brasseur D., Pons G., Sain-Raymond A., 'Le règlement européen de &quotmeilleurs médicaments pour les enfants en Europe&quot. Une chance pour la recherche et les soins en pédiatrie?' In: Delfosse M. L., Parizeau M. H., Amman J. P. La recherche clinique avec les enfants: à la croisée de l'éthique et du droit. Belgium, France, Quebec: Editions Anthemis, pp. 51-66.
Broich K., 'Committee for Medicinal Products for Human Use (CHMP) assessment on efficacy of antidepressants', Eur Neuropsychopharmacol, Vol. 19(5), pp. 305-308.
Celis P., Miglicacio G., Pedone E., Petracek J., Pinheiro M. H., Salmikangas P., Schneider C. K., 'Advanced therapies: Regulatory principles and practice', Regulatory Rapporteur, Vol. 6, pp. 12-16.
Celis P., Pedone E., 'The Committee for Advanced Therapies at the European Medicines Agency and the advanced therapies certification procedure', Drug Development, Vol. 4, pp. 64-67.
Eichler H. G., Abadie E., Raine J. M., Salmonson T., 'Safe drugs and the cost of good intentions', N Engl J Med, Vol. 360(14), pp. 1378-1380.
Eichler I., Saint-Raymond A., 'The EU paediatric regulation: the way forward or a barrier to progress?', RAJ Pharma, Vol. 20, pp. 347-348.
Fanciulli G., Tomasi P. A., Delitala A. P., Delitala G., 'Activation of alpha1-adrenoceptors inhibits growth hormone secretion in humans', Exp Clin Endocrinol Diabetes, Vol. 117(9), pp. 460-462.
Giezen T. J., Mantel-Teeuwisse A. K., Strauss S. M. J. M., Egberts T. C. G., Blackburn S., Persson I., Leufkens H. G. M., 'Evaluation of post-authorization safety studies in the first cohort of EU risk management plans at time of regulatory approval', Drug Saf, Vol. 32(12), pp. 1175-1187.
Goedecke T., Brosch S., Arlett P., 'EudraVigilance - the common EU database to support pharmacovigilance activities', Regulatory Rapporteur, Vol. 6(2), pp. 6-11.
Grein K., 'Pharmacovigilance and the European Medicines Agency: conduct of pharmacovigilance activities', In: Woodward, K. N. (ed.) Veterinary pharmacovigilance: adverse reactions to veterinary medicinal products. Wiley-Blackwell.
Jekerle V., Schröder C., Pedone E., 'Legal basis of the advanced therapies regulation', Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz, Vol. 53(1), pp. 4-8.
Ludolph A. C., Kassubek J., Landwehrmeyer B. G., Mandelkow E., Mandelkow E. M., Burn D. J., Caparros-Lefebvre D., Frey K. A., de Yebenes J. G., Gasser T., Heutink P., Höglinger G., Jamrozik Z., Jellinger K. A., Kazantsev A., Kretzschmar H., Lang A. E., Litvan I., Lucas J. J., McGeer P. L., Melquist S., Oertel W., Otto M., Paviour D., Reum T., Saint-Raymond A., Steele J. C., Tolnay M., Tumani H., van Swieten J. C., Vanier M. T., Vonsattel J. P., Wagner S., Wszolek Z. K., Reisensburg Working Group for Tauopathies With Parkinsonism, 'Tauopathies with parkinsonism: clinical spectrum, neuropathologic basis, biological markers, and treatment options', Eur J Neurol, Vol. 16(3), pp. 297-309.
Manolis E., Pons G., 'Proposals for model-based paediatric medicinal development within the current European Union regulatory framework', Br J Clin Pharmacol, Vol. 68(4), pp. 493–501.
Novelli G., Borgiani P., Ciccacci C., Di Daniele N., Sirugo G., Papaluca Amati M., 'Pharmacogenomics: role in medicines approval and clinical use', Public Health Genomics, Vol. 13(5), pp. 284-291.
Saint-Raymond A., 'Médicaments pédiatriques et recherche : un équilibre fragile à trouver entre risques et bénéfices', In: Delfosse M. L., Parizeau M. H., Amman J.P. La recherche clinique avec les enfants: à la croisée de l'éthique et du droit. Belgium, France, Quebec: Editions Anthemis.
Saint-Raymond A., Seigneuret N., 'The European paediatric initiative: 1 year of experience', Paediatr Drugs, Vol. 11(1), pp. 9-10.
Saint-Raymond A., Sweeney F., 'Clinical trials in developing countries: risk or opportunity?' Future Med Chem, Vol. 1(7), pp. 1193-1195.
Schneider C. K., Papaluca M., Kurki P., 'A European perspective on immunogenicity evaluation', Nat Biotechnol, Vol. 27(6), pp. 507-508.
Scientific Advisory Group on Antimicrobials of the Committee for Medicinal Products for Veterinary Use, 'Reflection paper on the use of third and fourth generation cephalosporins in food producing animals in the European Union: development of resistance and impact on human and animal health', J Vet Pharmacol Ther, Vol. 32(6), pp. 515-533.
Shah R. R., Saint Raymond A., 'Regulation of human medicinal products in the European Union', In: Griffin J. P. The textbook of pharmaceutical medicine. 6th ed. London: BMJ Books, pp. 444-499.
Shivji R., Purves J., Celis P., 'European Medicines Agency: influenza pandemic preparedness'. Risk Wise: Epidemics, ISBN: 0-9536140-6-9, pp. 36-39.


Back to top

Blackburn S., 'The European Network of Centres in Pharmacoepidemiology and Pharmacovigilance', PRM Newsletter, Vol. 0, pp. 5-6.
Blind E., 'Twenty years of progress with parathyroid hormone (PTH): from specialized and &quotdifficult&quot measurement to common laboratory parameter and treatment option in osteoporosis', Clin Lab, Vol. 54, pp. 439-449.
De Clercq K., Goris N., Barnett P. V., Mackay D. K., 'FMD vaccines: reflections on quality aspects for applicability in European disease control policy', Transbound Emerg Dis, Vol. 55(1), pp. 46-56.
De Clercq K., Goris N., Barnett P. V., Mackay D. K., 'The importance of quality assurance/quality control of diagnostics to increase the confidence in global foot-and-mouth disease control', Transbound Emerg Dis, Vol. 55(1), pp. 35-45.
Eichler H. G., Pignatti F., Flamion B., Leufkens H., Breckenridge A., 'Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma', Nat Rev Drug Discov, Vol. 7(10), pp. 818-826.
Hauben M., Vogel U., Maignen F., 'Number needed to detect: nuances in the use of a simple and intuitive signal detection metric', Pharm Med, Vol. 22(1), pp. 13-22.
Llinares J., 'Orphan designation in the EU: an overview and key achivements', Regulatory Rapporteur, November 2008, pp. 5-9.
Neugebauer B., Drai C., Haase M., Hilger A., Keller-Stanislawski B., Laitinen-Parkkonen P., Mentzer D., Rasmussen C., Ratignier C., Seitz R., 'Factor VIII products and inhibitor development: concepts for revision of European regulatory guidelines', Haemophilia, Vol. 14(1), pp. 142-144.
Ormarsdottir S., Reginster J. Y., Abadie E., 'European regulatory perspectives for innovative therapies', Osteoporos Int, Vol. 19(6), pp. 725-731.


Back to top

Grein K., Papadopoulos O., Tollis M., 'Safe use of vaccines and vaccine compliance with food safety requirements', Rev Sci Tech, Vol. 26(2), pp. 339-350.
Mackay D., 'Authorisation within the European Union of vaccines against antigenically variable viruses responsible for major epizootic diseases', Rev Sci Tech, Vol. 26(2), pp. 421-428.

How useful was this page?

Add your rating
8 ratings
5 ratings
5 ratings
5 ratings