European Medicines Agency / health-technology-assessment-body workshop on parallel scientific advice in drug development

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TitleEuropean Medicines Agency / health-technology-assessment-body workshop on parallel scientific advice in drug development
Date26/11/2013 - 26/11/2013
LocationEuropean Medicines Agency, London, UK
SummaryThe European Medicines Agency (EMA) is holding a one-day workshop on parallel scientific advice with health-technology-assessment (HTA) bodies on evidence-generation in human-medicine development. The workshop is a joint undertaking of the EMA, HTA bodies and developers. Registration closed. Places limited.

All documents

Name Language First published Last updated
Report from the European Medicines Agency / health-technology-assessment-body workshop on parallel scientific advice in drug development on 26 November 2013 (English only) 08/05/2014  
Draft best practice guidance for pilot European Medicines Agency health technology assessment parallel scientific advice procedures (English only) 08/05/2014  
Dates of forthcoming SEED early dialogue meetings and deadlines for briefing book submissions in 2014 (English only) 03/01/2014  
Call for expression of interest to the attention of healthcare product (pharmaceuticals or medical devices) developers (English only) 06/12/2013  
Agenda - European Medicines Agency / health-technology-assessment-body workshop on parallel scientific advice in drug development (English only) 10/10/2013 22/11/2013
Expression of interest form - European Medicines Agency / health-technology-assessment-body workshop on parallel scientific advice in drug development (English only) 14/06/2013  
Speaker biographies - European Medicines Agency / health-technology-assessment-body workshop on parallel scientific advice in drug development (English only) 25/11/2013  
Presentation - The patient-advocate view (Yann Le Cam) (English only) 26/11/2013  
Presentation - The health-technology-assessment view (David Barnett) (English only) 26/11/2013  
Presentation - European Commission (Flora Giorgio) (English only) 26/11/2013  
Presentation - Regulatory view (Robert Hemmings) (English only) 26/11/2013  
Presentation - Health-technology-assessment-body (HTA) view (Leeza Osipenko) (English only) 26/11/2013  
Presentation - Industry view (Britta Paschen) (English only) 26/11/2013  
Presentation - Industry perspective on advice models (Christine Mayer-Nicolai, Adrian Griffin, Judith Creba and James Anderson) (English only) 26/11/2013  
Presentation - European Medicines Agency and health-technology-assessment advice in Europe: Experience of biotech small and medium-sized enterprises (Paolo Morgese) (English only) 26/11/2013  
Presentation - European Network for Health Technology Assessment joint action 2 work programme 7: Multi-health-technology-assessment early dialogues (Mira Pavlovic, Francois Meyer) (English only) 26/11/2013  
Presentation - Regulatory view (Jan Mueller-Berghaus) (English only) 26/11/2013  
Presentation - Health-technology-assessment-body (HTA) view (Seren Phillips) (English only) 26/11/2013  
Presentation - Breakout session 1: Principles and policy (English only) 27/11/2013  
Presentation - Breakout session 2: Science and data (English only) 27/11/2013  
Presentation - Breakout session 3: Process and procedures (English only) 27/11/2013  
Presentation - Breakout session 4: Special issues (English only) 27/11/2013  

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