European Medicines Agency / health-technology-assessment-body workshop on parallel scientific advice in drug development
Date:
26/11/2013
Location:
European Medicines Agency, London, UK
The 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.
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Report from the European Medicines Agency / health-technology-assessment-body workshop on parallel scientific advice in drug development on 26 November 2013 (PDF/251.53 KB)
First published: 08/05/2014
Last updated: 08/05/2014 -
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Draft best practice guidance for pilot European Medicines Agency health technology assessment parallel scientific advice procedures (PDF/291.49 KB)
Draft: consultation closed
First published: 08/05/2014
Last updated: 08/05/2014
Consultation dates: 08/05/2014 to 14/07/2014
EMA/109608/2014 -
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Dates of forthcoming SEED early dialogue meetings and deadlines for briefing book submissions in 2014 (PDF/16.55 KB)
First published: 03/01/2014
Last updated: 03/01/2014 -
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Call for expression of interest to the attention of healthcare product (pharmaceuticals or medical devices) developers (PDF/407.04 KB)
First published: 06/12/2013
Last updated: 06/12/2013 -
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Agenda - European Medicines Agency / health-technology-assessment-body workshop on parallel scientific advice in drug development (PDF/89.43 KB)
First published: 10/10/2013
Last updated: 22/11/2013
EMA/620552/2013 -
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Expression of interest form - European Medicines Agency / health-technology-assessment-body workshop on parallel scientific advice in drug development (PDF/279.21 KB)
First published: 14/06/2013
Last updated: 14/06/2013 -
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Speaker biographies - European Medicines Agency / health-technology-assessment-body workshop on parallel scientific advice in drug development (PDF/569.56 KB)
First published: 25/11/2013
Last updated: 25/11/2013
EMA/719506/2013 -
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Presentation - The patient-advocate view (Yann Le Cam) (PDF/853.92 KB)
First published: 26/11/2013
Last updated: 26/11/2013 -
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Presentation - The health-technology-assessment view (David Barnett) (PDF/963.2 KB)
First published: 26/11/2013
Last updated: 26/11/2013 -
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Presentation - European Commission (Flora Giorgio) (PDF/194.99 KB)
First published: 26/11/2013
Last updated: 26/11/2013 -
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Presentation - Regulatory view (Robert Hemmings) (PDF/149.98 KB)
First published: 26/11/2013
Last updated: 26/11/2013 -
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Presentation - Health-technology-assessment-body (HTA) view (Leeza Osipenko) (PDF/424.93 KB)
First published: 26/11/2013
Last updated: 26/11/2013 -
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Presentation - Industry view (Britta Paschen) (PDF/88.85 KB)
First published: 26/11/2013
Last updated: 26/11/2013 -
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Presentation - Industry perspective on advice models (Christine Mayer-Nicolai, Adrian Griffin, Judith Creba and James Anderson) (PDF/299.29 KB)
First published: 26/11/2013
Last updated: 26/11/2013 -
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Presentation - European Medicines Agency and health-technology-assessment advice in Europe: Experience of biotech small and medium-sized enterprises (Paolo Morgese) (PDF/271.66 KB)
First published: 26/11/2013
Last updated: 26/11/2013 -
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Presentation - European Network for Health Technology Assessment joint action 2 work programme 7: Multi-health-technology-assessment early dialogues (Mira Pavlovic, Francois Meyer) (PDF/427.37 KB)
First published: 26/11/2013
Last updated: 26/11/2013 -
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Presentation - Regulatory view (Jan Mueller-Berghaus) (PDF/473.07 KB)
First published: 26/11/2013
Last updated: 26/11/2013 -
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Presentation - Health-technology-assessment-body (HTA) view (Seren Phillips) (PDF/94.65 KB)
First published: 26/11/2013
Last updated: 26/11/2013 -
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Presentation - Breakout session 1: Principles and policy (PDF/190.42 KB)
First published: 27/11/2013
Last updated: 27/11/2013 -
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Presentation - Breakout session 2: Science and data (PDF/146.25 KB)
First published: 27/11/2013
Last updated: 27/11/2013 -
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Presentation - Breakout session 3: Process and procedures (PDF/147.98 KB)
First published: 27/11/2013
Last updated: 27/11/2013 -
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Presentation - Breakout session 4: Special issues (PDF/203.45 KB)
First published: 27/11/2013
Last updated: 27/11/2013