Cancer Medicines Forum: December 2022

• Date:
  Tuesday, 20 December 2022
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

The third Cancer Medicines Forum took place on the 20th December 2022 and looked at challenges around the feasibility of having randomised clinical trials in the post-authorisation setting. A presentation on the EMA framework for imposing post-authorisation safety and efficacy studies was discussed and discussions took place on the development of criteria to guide the choice of methodology and related quality standards for conducting post-authorisation studies.

The CMF aims to explore how EMA can contribute towards addressing remaining uncertainties about the use of cancer medicines in clinical practice.

The forum brings together representatives of academic organisations from EMA’s Healthcare Professionals Working Party and the European medicines regulatory network.

The results of discussions will support the prioritisation of actions to fight cancer in EMA's Regulatory Science Strategy to 2025 and Academia Collaboration Matrix Action Plan.

The meetings of the forum are by invitation only.

Documents

Minutes of the Cancer Medicines Forum - 20 December 2022

Presentation - Post-authorisation Safety and Efficacy studies (C. Voltz-Girolt, EMA)

Presentation - Feasibility of post- authorization randomized controlled trials for conditionally authorized anticancer medicines - a multistakeholder perspective (C. van Hattem; A. de Jong; J. de Groot; L. Bloem, Utrecht University)