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

• Date:
  Tuesday, 26 November 2013
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

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.

Documents

Report from the European Medicines Agency / health-technology-assessment-body workshop on parallel scientific advice in drug development on 26 November 2013

Summary:

Report from the public workshop hosted by the European Medicines Agency in London on 26 November 2013EMA-HTA workshop: Bringing together stakeholders for early dialogue in medicines

development

Draft best practice guidance for pilot European Medicines Agency health technology assessment parallel scientific advice procedures

Consultation dates: 08/05/2014 to 14/07/2014Draft: consultation closedReference Number: EMA/109608/2014

Dates of forthcoming SEED early dialogue meetings and deadlines for briefing book submissions in 2014

Call for expression of interest to the attention of healthcare product (pharmaceuticals or medical devices) developers

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

Reference Number: EMA/620552/2013

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

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

Reference Number: EMA/719506/2013

Presentation - The patient-advocate view (Yann Le Cam)

Presentation - The health-technology-assessment view (David Barnett)

Presentation - European Commission (Flora Giorgio)

Presentation - Regulatory view (Robert Hemmings)

Presentation - Health-technology-assessment-body (HTA) view (Leeza Osipenko)

Presentation - Industry view (Britta Paschen)

Presentation - Industry perspective on advice models (Christine Mayer-Nicolai, Adrian Griffin, Judith Creba and James Anderson)

Presentation - European Medicines Agency and health-technology-assessment advice in Europe: Experience of biotech small and medium-sized enterprises (Paolo Morgese)

Presentation - European Network for Health Technology Assessment joint action 2 work programme 7: Multi-health-technology-assessment early dialogues (Mira Pavlovic, Francois Meyer)

Presentation - Regulatory view (Jan Mueller-Berghaus)

Presentation - Health-technology-assessment-body (HTA) view (Seren Phillips)

Presentation - Breakout session 1: Principles and policy

Presentation - Breakout session 2: Science and data

Presentation - Breakout session 3: Process and procedures

Presentation - Breakout session 4: Special issues

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