Thirteenth meeting of the industry stakeholder platform on research and development support

• Date:
  Monday, 2 December 2024, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

This is the thirteenth 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 to development support activities, such as scientific advice and qualification, as well as specifics for paediatric and orphan medicines.

This meeting focuses on:

• recent developments to optimise support for programme-specific evidence planning;
• specifics of Scientific Advice for paediatric developments;
• initial work of the Focus group to explore opportunities for the use of Real World Data (RWD) and the generation of Real World Evidence (RWE);
• updates on processing Scientific Advice requests regarding New Fee Regulation;
• onboarding of paediatric procedures onto IRIS;
• discussion on experience with Portfolio and Technology meetings (PTMs).

Registration

• Registration by invitation only

Documents

Agenda – 13th Industry stakeholder platform on research and development support

Highlight report - 13th Industry stakeholder platform on research and development support

Reference Number: EMA/578907/2024

Presentation - Portfolio and Technology Meetings (Enrico Tognana)

Presentation - Updates from EMA on scientific advice and PRIME (Iordanis Gravanis)

Presentation - Stepwise PIP (Chrissi Pallidis)

Presentation - Focus group on use of RWD and generation of RWE (Patrice Verpillat)

Presentation - NFR impact on RnD processes (Tarita Toufexi)