European Medicines Agency/European Federation of Pharmaceutical Industries and Associations workshop on the importance of dose finding and dose selection for the successful development, licensing and lifecycle management of medicinal products

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TitleEuropean Medicines Agency/European Federation of Pharmaceutical Industries and Associations workshop on the importance of dose finding and dose selection for the successful development, licensing and lifecycle management of medicinal products
Date04/12/2014 - 05/12/2014
LocationEuropean Medicines Agency, London, UK
SummaryEMA/EFPIA workshop is planned for 4-5 December 2014 to discuss the importance of dose finding and dose selection for the successful development, licensing and lifecycle management of medicinal products. Registration: please register by 19 September 2014 using the registration form provided.

All documents

Name Language First published Last updated
Report from the European Medicines Agency/European Federation of Pharmaceutical Industries and Associations workshop on the importance of dose finding and dose selection for the successful development, licensing and lifecycle management of medicinal products (English only) 17/04/2015  
Agenda - European Medicines Agency/European Federation of Pharmaceutical Industries and Associations (EFPIA) workshop on the importance of dose finding and dose selection for the successful development, licensing and lifecycle management of medicinal products (English only) 23/06/2014 07/01/2015
Presentation - Workshop opening (Rob Hemmings, Efthymios Manolis) (English only) 07/01/2015  
Presentation - Dose selection in drug development and regulation: possible future direction (Richard Lalonde, Donald Stanski) (English only) 07/01/2015  
Presentation - Dose response assessments: guidance, experience, expectations (Vikram Sinha) (English only) 07/01/2015  
Presentation - Pharmacometrics: a solid scientific basis for pharmacostatistical dose finding (Mick Looby) (English only) 07/01/2015  
Presentation - Sarm I/Tadalafil pgase II combination study for erectile dysfunction: modeling and simulation to optimize study design (Charles Benson) (English only) 07/01/2015  
Presentation - Regulatory comments: pharmacometric principles in dose finding (Terry Shepard, Sofia Friberg Hietala) (English only) 07/01/2015  
Presentation - An adaptive dose-finding study in postoperative dental pain. MCP-Mod (Björn Bornkamp) (English only) 07/01/2015  
Presentation - Averaged model based decision making for dose selection studies (Yasunori Aoki, Bengt Hamrén, Daniel Röshammar, Andrew C. Hooker) (English only) 07/01/2015  
Presentation - Model based dose finding: discussion of presentations given by Björn Bornkamp and Andrew Hooker (Norbert Benda) (English only) 07/01/2015  
Presentation - Meta-analyses of clinical dose response (N. Thomas, D. Roy, V. Somayaji, K. Sweeney) (English only) 07/01/2015  
Presentation - Ph 2/3 trial for selepressin in the treatment of vasopressor-dpendent septic shock (Scott Berry) (English only) 07/01/2015  
Presentation - Ph 2/3 trial for selepressin (Martin Posch) (English only) 07/01/2015  
Presentation - Session 2 summary: designs and methods (Jose Pinheiro) (English only) 07/01/2015  
Presentation - Dosing: examples from antipsychotics (Luca Pani) (English only) 07/01/2015  
Presentation - Ph2a dose selection based on the relationship between PK and target occupancy (Mona Alameddine, Patricia Sanwald Ducray) (English only) 07/01/2015  
Presentation - A systems pharmacology perspective on the clinical development of fatty acid amide hydrolase inhibitors for pain (Piet van der Graaf) (English only) 07/01/2015  
Presentation - Dose finding for a β-lactam – β-lactamase inhibitor combination (Shampa Das, Astra Zeneca) (English only) 07/01/2015  
Presentation - Mechanism-based PKPD-models for selection of dosing regimens for antibiotics (Lena Friberg, Anders Kristoffersson, Elisabet Nielsen) (English only) 07/01/2015  
Presentation - General principles of antiviral dose selection (Filip Josephson) (English only) 07/01/2015  
Presentation - Cabozantinib (Cometriq) (Frans Opdam) (English only) 07/01/2015  
Presentation - Shifting the MTD paradigm in oncology (Kevin Smart, Georgina Meneses-Lorente) (English only) 07/01/2015  
Presentation - An oncology systems pharmacology approach to dose selection (James Yates) (English only) 07/01/2015  
Presentation - Agonists with different levels of affinity (Peter Mol) (English only) 07/01/2015  
Presentation - Dose-finding in the cardiovascular therapeutic area: the novel oral anticoagulants (Antonio Gómez-Outes) (English only) 07/01/2015  
Presentation - Key learnings from otamixaban development (Christophe Gaudin) (English only) 07/01/2015  
Presentation - Dose - response - anticoagulants (Robert Temple) (English only) 07/01/2015  
Presentation - Use of dose-exposure-response model in immunology/transplantation: general considerations and case study (T Dumortier, M Looby, Y Wang) (English only) 07/01/2015  
Presentation - Regulatory and physician view (Lisbeth Barkholt) (English only) 07/01/2015  
Presentation - Regulatory view (Flora Musuamba Tshinanu) (English only) 13/03/2015  
Presentation - The importance of D-E-R characterisation in dose selection, labelling and B/R - children (Dirk Mentzer, Ine Rusten) (English only) 07/01/2015  
Presentation - The importance of D-E-R characterisation in dose selection, labelling and B/R - Children (Anne Brochot) (English only) 07/01/2015  
Presentation - D-E-R characterisation in dose selection, labelling and B/R assessment: focus on the elderly (Terry Shepard, Sue Morgan) (English only) 07/01/2015  
Presentation - Sub sopulation: the elderly - How can modelling and simulation inform understanding of safety and efficacy? (Amy S. Y. Cheung) (English only) 07/01/2015  
Presentation - Dose and schedule determination and amendments of EU centrally approved products (CAPs) (Falk Ehmann) (English only) 07/01/2015  
Presentation - Impact of D-E-R information on regulatory approval and post-authorisation commitments: FDA perspective (Yaning Wang, Vikram Sinha) (English only) 07/01/2015  
Presentation - Regulatory evaluation and perspectives on dose-exposure-response information in new drug applications (Naoyuki Yabana, Naomi Nagai) (English only) 07/01/2015  
Presentation - Dose selection in drug development and regulation: possible future direction concluding industry thinking (Richard Lalonde, Donald Stanski) (English only) 07/01/2015  

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