Webinar on the use of platform approaches in the non-clinical and clinical domains

• Date:
  Monday, 02 March 2026 , 09:25 - 12:30 Amsterdam time (CET)
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands
  Live broadcast

Event summary

The European Medicines Agency organises a webinar bringing together regulators and medicine developers to discuss the use of platform approaches beyond the quality and manufacturing domains.

The proposal for the EU pharmaceutical legislation introduces the concepts of platform technologies and platform marketing authorisation.

The main objectives of the webinar are:

• Clarifying the current EU legal framework for the development and marketing of individualised therapies (n=1) and for the use of prior knowledge in Marketing Authorisation dossiers;
• Presenting case studies on the use of platform approaches in the non-clinical and clinical domains and exploring their possible applications and values; 
• Discussing the challenges and identify opportunities related to the use of platform approaches;
• Facilitating the implementation of the EU pharmaceutical legislation provisions on platform technologies and platform marketing authorisation.

Documents

Agenda - Webinar on the use of platform approaches in the non-clinical and clinical domains

Presentation - Session 1 - Current regulatory routes for individualised therapies (I. Reischl-Kok)

Presentaion - Session 1 - Regulatory experience on the use of prior knowledge and platform approaches (EMA)

Presentation - Session 1 - Provisions of the new EU pharmaceutical legislation on platform approaches (F. Schmidt)

Presentation - Session 2 case 1 - academia (A. Aartsma-Rus)

Presentation - Session 2 case 2 - large pharma (M. Bilanin)

Presentation - Session 2 case 3 - small and mid-sized enterprises (A. Natz)

Video recording