EMA – Thirteenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines – 22 November 2024 (invitation only)

EMA is hosting the thirteenth industry stakeholder platform on the operation of the centralised procedure for human medicines.

This will be the thirteenth in a series of regular meetings between regulators and representatives of industry stakeholder organisations. The meeting aims to foster a constructive exchange on general updates and more focused discussions on specific processes and issues to support continuous improvement.

This meeting will focus on: 

• transitional measures to implement the new variation regulation;
• ePI pilots readout, learnings and next steps;

focus group on cancer medicines pathfinder regulatory interactions.

The meeting will also inform on and discuss the following:

• Ongoing initiatives on the centralised procedure
• Dynamic regulatory assessment
• Lifecycle management of combination products at post-authorisation
• Clinical study data pilot
• Public consultation to review the QRD template for product information

The registration is by invitation only.

More information on this event on the EMA Website.