Cancer medicines forum meeting 4 December 2023

Date

Monday, 4 December 2023, All day

Location

European Medicines Agency, Amsterdam, the Netherlands

Event summary

The sixth Cancer Medicines Forum took place 4 December 2023 and welcomed guests from the NCAPR representatives from the Belgian, Dutch, Portuguese, Slovenian and Spanish agencies.

A summary of the activities/achievements of the CMF was presented by EORTC. A presentation on the current regulatory framework was given by EMA sharing possible solutions to address treatment optimisation research questions in the pre-authorisation setting as well as in post-authorisation studies.

The preparation of the CMF workshop was discussed; it will take place 5 April and aims to provide specific public communication on the CMF output.

The objectives of the workshop are:

  • to communicate externally CMF’s achievements and expand stakeholders’ participation;
  • to discuss the principles to structure treatment optimisation in the regulatory process;
  • to identify regulatory tools and joint initiatives, as well as supporting and prioritising independent clinical research on treatment optimisation.

The CMF will address specific disease types where treatment optimisation should be prioritised. Methodological aspects and guidelines for designing treatment optimisation studies need to be further discussed as well as how optimisation studies can be linked to the regulatory framework for drug development and evaluation.

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.

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