Fifth industry stakeholder platform on research and development support
Date:
16/11/2020
Location:
Virtual meeting
This is the fifth in a series of regular meetings between regulators and representatives of industry stakeholder organisations. It addresses all areas of product-development support, from scientific advice and innovation support, as well as specifics for paediatric and orphan medicines.
This meeting focuses on the evolution of the scientific advice framework, the recent launch of IRIS for scientific advice, integrated drug-device combination products (implementation of Art. 117), enhancement of the PRIME scheme, progress with the paediatric action plan and progressing the concept of patient-centred development in practice.
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Highlight report - Fifth industry stakeholder platform on research and development support (PDF/135.57 KB)
First published: 21/01/2021
EMA/619777/2020 -
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Presentation - Welcome to the fifth industry stakeholder platform on research and development support (M.Berntgen, EMA) (PDF/134.99 KB)
First published: 21/01/2021 -
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Presentation - Experience with the R&D stakeholder platform (M.Berntgen, EMA) (PDF/279.64 KB)
First published: 21/01/2021 -
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Presentation - Reflections on iterative advice (V.Jekerle, EMA) (PDF/155.76 KB)
First published: 21/01/2021 -
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Presentation - First learnings from accelerated scientific advice for COVID 19 medicines (E.Manolis, EMA) (PDF/153.99 KB)
First published: 21/01/2021 -
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Presentation - Experience from the pilot for tailored scientific advice on biosimilars (A.Baron, EMA) (PDF/149.08 KB)
First published: 21/01/2021 -
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Presentation - Launch of IRIS for Scientific Advice (P.Tomasi, T.Toufexi, EMA) (PDF/346.84 KB)
First published: 21/01/2021 -
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Presentation - Follow-up on the practical arrangements regarding integrated drug-device combination products (A.Ritzhaupt, EMA) (PDF/534.94 KB)
First published: 21/01/2021 -
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Presentation - Enhancement of the PRIME scheme (F.Cerreta, EMA) (PDF/156.29 KB)
First published: 21/01/2021 -
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Presentation - EMA EC Action Plan on Paediatrics - Progress update (G.Egger, EMA) (PDF/283.72 KB)
First published: 21/01/2021 -
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Presentation - Including patient preferences and patientreported outcomes in global development programmes, submissions and labels (F.Pignatti, EMA) (PDF/705.25 KB)
First published: 21/01/2021 -
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Presentation - Patient Engagement at EMA - Progressing the concept of patient-centered development in practice (N.Bere, J.Garcia, EMA) (PDF/354.4 KB)
First published: 21/01/2021