Sixth industry stakeholder platform on research and development support

• Date:
  Friday, 4 June 2021, All day
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

This is the sixth 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 combination products with medical devices / companion diagnostics, assessment of similarity for ATMPs, progressing the concept of patient-centred development in practice, scientific advice for continuous innovation in known molecules, 5-year review of the PRIME scheme and a status update from the ongoing discussions at the focus groups for Practical application of integrated development support and Concept of an ‘evolutionary’ PIP.

Documents

Highlight report - Sixth industry stakeholder platform on research and development support

Reference Number: EMA/326151/2021

Presentation - Medicinal products in combination with medical devices (C. Bouygues, P. Venneugues, EMA)

Presentation - Update on the implementation of the consultation procedure on Companion Diagnostic (CDx) (C. Bouygues, C. Vleminckx, EMA)

Presentation - Updated EC Q&A on similarity for ATMPs in the context of the Orphan legislation (C. Pothet, EMA)

Presentation - Progressing the concept of patient-centred development in practice (N. Bere, EMA)

Presentation - Five year review of the PRIME scheme (S. Ribeiro, EMA)

Presentation - Focus group on the concept of an ‘evolutionary’ PIP: Interim feedback (R. Bax, EMA)

Presentation - Study on submission of RWD/RWE in MAAs and EoIs-2018-2019: Preliminary results (X Kurz, EMA)