Seventh industry stakeholder platform on research and development support
Table of contents
Date:
23/11/2021
Location:
Online
This is the seventh in a series of regular meetings between regulators and representatives of industry stakeholder organisations. It addresses all areas of evidence generation along the medicine’s life-cycle and related product-development support activities, such as scientific advice and qualification, as well as specifics for paediatric and orphan medicines.
This meeting will focus on various activities contributing to renovating the scientific advice offering, review of the experience with the PRIME scheme, progressing the integration of Real World Evidence into medicines development and considerations regarding the concept of an ‘evolutionary’ paediatric investigation plan.
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Highlight report from the seventh Industry stakeholder platform on research and development support (PDF/211.97 KB)
First published: 17/03/2022
EMA/714427/2021 -
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Presentation - Revamping the Scientific Advice process (I.Gravanis, EMA) (PDF/183.87 KB)
First published: 17/03/2022 -
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Presentation - HTA collaboration parallel EMA/ HTA Joint Scientific Consultation (A.Behring, G-BA, EUnetHTA21; T.Olski, EMA) (PDF/332.97 KB)
First published: 17/03/2022 -
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Presentation - Review of the PRIME scheme: learnings and opportunities (S.Ribeiro, F.Cerreta, EMA); B.Sepodes (CHMP); M.Schussler-Lenz (CAT) (PDF/264.83 KB)
First published: 17/03/2022 -
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Presentation - Report from the Focus group on the concept of an ‘evolutionary’ PIP (R.Bax, EMA; A.Braun-Scherhag, EUCOPE; A.Joos, EFPIA; R.Vart, EuropaBio) (PDF/286.67 KB)
First published: 17/03/2022 -
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Presentation - Seventh Industry stakeholder platform on research and development support (P.Arlett, EMA) (PDF/757.58 KB)
First published: 17/03/2022