Thirteenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines

• Date:
  Friday, 22 November 2024 , 09:00 - 14:00 Amsterdam time (CET)
• Location:
  Online
  European 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

Documents

Highlight report - Thirteenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines

Reference Number: EMA/544205/2024

Agenda - Thirteenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines

Reference Number: EMA/468836/2024

Presentation - Transitional measures to implement the new variation regulation (T. Girard, EMA)

Presentation - ePI Pilots readout, learnings and next steps (J. Garcia; E. Scanlan, EMA)

Presentation - Focus group on cancer medicines pathfinder regulatory interactions (F.Pignatti, EMA)

Presentation - Ongoing initiatives on the centralised procedure (F. Day, EMA)

Presentation - Clinical Study Data Pilot (E. Psarelli, EMA)

Presentation - Lifecycle management of combination products at post-authorisation (C.Bouygues, C.Vicenzi, EMA)

Presentation - Clinical Data Publication - next steps consultation (K.Quigley, EMA)

Contact point

• [e-mail]