Fourth industry stakeholder platform on research and development support
This is the fourth in a series of regular meetings between regulators and representatives of industry stakeholder organisations, hosted by the European Medicines Agency (EMA). It addresses all areas of product-development support, from scientific advice, through specifics for paediatric and orphan medicines, to innovation support.
This meeting will focus on the future regulation of integrated drug-device combinations, experience with the qualification of digital technology proposals, current challenges in developments with biomarkers and opportunities for 'post-licensing evidence generation' proposals in scientific advice. It will also provide updates on activities on:
- next generation sequencing;
- Parallel joint scientific consultation with regulators and health technology assessment bodies;
- orphan designation reviews;
- topics from the
paediatric action plan
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Agenda – Industry stakeholder platform on research and development support (PDF/144.21 KB)
Adopted
First published: 22/11/2018
EMA/769203/2018 -
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Highlight report of the fourth industry stakeholder platform on research and development support on 23 November 2018 (PDF/142.32 KB)
Adopted
First published: 05/02/2019
EMA/845782/2018 -
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Presentation - Exchange on the practical considerations for the future regulation of integrated drug-device combinations (I. Hayes, A. Ritzhaupt) (PDF/710.46 KB)
First published: 16/01/2019 -
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Presentation - Important considerations for successful qualification proposals for digital technologies (F. Cerreta) (PDF/675.51 KB)
First published: 16/01/2019 -
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Presentation - Parallel Consultations (J. Moseley) (PDF/1.45 MB)
First published: 16/01/2019 -
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Presentation - PDCO-CHMP interaction (C. Pallidis) (PDF/248.67 KB)
First published: 16/01/2019 -
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Presentation - Post Licensing Evidence Generation (PLEG) (J. Moseley) (PDF/206.24 KB)
First published: 16/01/2019 -
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Presentation - Reflection on similarity assessment (L. Liebers) (PDF/319.01 KB)
First published: 16/01/2019 -
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Presentation - Significant benefit (SB) and relative effetiveness assessment (REA) for prphan medicinal products (OMP) (K. Larsson) (PDF/539.94 KB)
First published: 16/01/2019 -
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Presentation - Targeting histology-independent indications and resulting challenges in the context of orphan designations (F. Pignatti, P. Demolis) (PDF/389.08 KB)
First published: 16/01/2019