Fifth industry stakeholder platform on research and development support

• Date:
  Lunedì, 16 Novembre 2020, All day
• Sede:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

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.

Documents

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

Reference Number: EMA/619777/2020

Presentation - Welcome to the fifth industry stakeholder platform on research and development support (M.Berntgen, EMA)

Presentation - Experience with the R&D stakeholder platform (M.Berntgen, EMA)

Presentation - Reflections on iterative advice (V.Jekerle, EMA)

Presentation - First learnings from accelerated scientific advice for COVID 19 medicines (E.Manolis, EMA)

Presentation - Experience from the pilot for tailored scientific advice on biosimilars (A.Baron, EMA)

Presentation - Launch of IRIS for Scientific Advice (P.Tomasi, T.Toufexi, EMA)

Presentation - Follow-up on the practical arrangements regarding integrated drug-device combination products (A.Ritzhaupt, EMA)

Presentation - Enhancement of the PRIME scheme (F.Cerreta, EMA)

Presentation - EMA EC Action Plan on Paediatrics - Progress update (G.Egger, EMA)

Presentation - Including patient preferences and patientreported outcomes in global development programmes, submissions and labels (F.Pignatti, EMA)

Presentation - Patient Engagement at EMA - Progressing the concept of patient-centered development in practice (N.Bere, J.Garcia, EMA)