Ninth industry stakeholder platform on research and development support

• Date:
  Monday, 5 December 2022, All day
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

This is the ninth 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 will focus on:

• recent developments to address scientific advice capacity and scope,
• progress with parallel Joint Scientific Consultations,
• implementation of the recommendations from the PRIME 5-year review,
• development of a pilot for scientific advice on developments concerning e.g. drug-device combinations, and
• follow-up on strengthening patient-centric development.

A delivery report of the EMA/EC Paediatric Action Plan will also be presented along with changes to the Paediatric Annual Report preparation.

Closing reports from the Focus group on review and strengthening the framework for qualification of novel methodologies and the Focus group on the practical application of principles relevant for the PIP framework will be discussed.

Documents

Agenda - Ninth industry stakeholder platform on research and development support

Reference Number: EMA/832164/2022

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

Reference Number: EMA/923972/2022

Presentation - Recent developments to address scientific advice capacity and scope (Iordanis Gravanis)

Presentation - Focus Group on review and strengthening the framework for Qualification of Novel Methodologies (QoNM) (Thorsten Vetter)

Presentation - Progressing parallel Joint Scientific Consultations (Antje Behring, Thorsten Olski)

Presentation - PRIME Implementation of recommendations based on first 5 years’ experience with the scheme (Kevin Cunningham)

Presentation - EMA/EC action plan on paediatrics 2018-2022 (Gunter Egger)

Presentation - Closing report from the Focus group on the practical application of principles relevant for the PIP framework (Chrissi Pallidis, Sabine Scherer, Gesine Bejeuhr, Marcello Milano)

Presentation - Changes to the preparation of the Paediatric Annual Report to the EC (Isabel Sanchez)

Presentation - Medical Device Expert Panels’ Activities (Silvy da Rocha Dias, Miguel Antunes)

Presentation - Follow-up on strengthening patient-centric development (Juan Garcia Burgos)