Thirteenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines
EventHumanRegulatory and procedural guidanceMedicines
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- The original event time is:
- Viernes, Noviembre 22, 2024 - 09:00 - 14:00 Amsterdam time (CET)
Date
- , -
Lugar
- OnlineEuropean Medicines Agency, Amsterdam, the Netherlands
Event summary
EMA is hosting the thirteenth industry stakeholder platform on the operation of the centralised procedure for human medicines.
This is 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 focuses 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 also informs on and discusses 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
- Clinical Data Publication - next steps consultation