Tenth industry stakeholder platform on research and development support

• Date:
  Tuesday, 11 July 2023, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

This is the tenth 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.

The meeting includes information on:

• progress with the implementation of the recommendations to further strengthen the PRIME scheme,
• progress with the implementation of initiatives to optimise the application of the PIP framework,
• cooperation at the HTA/regulatory interface,
• development of complex generics,
• update on latest developments in scientific advice along with reports from both the multi-stakeholder workshop on qualification of novel methodologies and from the Focus group to discuss opportunities for provision of scientific advice for medicinal product developments also comprising of devices and/or companion diagnostic.

Documents

Agenda - Tenth industry stakeholder platform on research and development support

Reference Number: EMA/168978/2023

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

Reference Number: EMA/326290/2023

Presentation - Update on latest developments in scientific advice (I.Gravanis, EMA)

Presentation - PRIME: Implementation of new initiatives to further strengthen the PRIME scheme (K. Cunningham, A. Gross, EMA)

Presentation - EMA multistakeholder workshop on Qualification of Novel Methodologies (QoNM) - initial feedback from the discussions (T. Vetter, EMA)

Presentation - Cooperation at the HTA/regulatory interface (S.Said, G-BA; T.Olski, EMA)

Presentation - Experience from sPIP pilot (C, Pallidis, S. Scherer, EMA)

Presentation - Revision of the key elements and the summary report template (R. De Lisa, C. Pallidis, EMA)

Presentation - Proposals moving forward to facilitate the scientific dialogue on drug-device and drug-companion diagnostic combinations within the current regulatory framework and potentially in the future (S. Aarum, EMA)