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

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