Ninth industry stakeholder platform on research and development support

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.