Seventh industry stakeholder platform on research and development support

• Date:
  Tuesday, 23 November 2021, All day
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

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.

Documents

Highlight report from the seventh Industry stakeholder platform on research and development support

Reference Number: EMA/714427/2021

Presentation - Revamping the Scientific Advice process (I.Gravanis, EMA)

Presentation - HTA collaboration parallel EMA/ HTA Joint Scientific Consultation (A.Behring, G-BA, EUnetHTA21; T.Olski, EMA)

Presentation - Review of the PRIME scheme: learnings and opportunities (S.Ribeiro, F.Cerreta, EMA); B.Sepodes (CHMP); M.Schussler-Lenz (CAT)

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)

Presentation - Seventh Industry stakeholder platform on research and development support (P.Arlett, EMA)