EMA multi-stakeholder workshop on the clinical evaluation of therapeutic radiopharmaceuticals in oncology

• Date:
  Monday, 17 November 2025 , 09:00 - 15:00 Amsterdam time (CET)
• Location:
  European Medicines Agency, Amsterdam, the Netherlands
  Live broadcast

Workshop postponed to a later date

We regret to inform you that due to the need to ensure the participation of key regulatory stakeholders and to address other organisational considerations, the workshop has been postponed by a few months.

We will announce the new date as soon as possible.

Event summary

In line with the Oncology Working Party work plan for 2025-2027, this workshop is organised to have a multi-stakeholder perspective on the challenges in drug development and marketing authorisation applications of therapeutic radiopharmaceuticals. 

The workshop complements the recent public consultation on the concept paper on clinical evaluation of therapeutic radiopharmaceuticals in oncology (EMA/CHMP/451705/2024). The upcoming guideline aims to define the clinical data package required in support for the benefit-risk evaluation at marketing authorisation level.

The aims of the workshop are:

• to present the current regulatory requirements for the clinical development of radiopharmaceuticals in support of a marketing authorisation application;
• to identify aspects that are specific for the development of therapeutic radiopharmaceuticals in oncology that need to be addressed in the future guideline, which will complement the more general Guideline on the clinical evaluation of anticancer medicinal products currently under revision;
• to present and discuss with stakeholders (healthcare professionals, patients, industry representatives) on the way to generate the clinical data necessary for dossiers to obtain a marketing authorisation, including strategies for long-term safety follow-up.

Workshop structure: 

• Session 1: Dosimetry data requirements 
• Session 2: Safety data requirements 

Note: clinical development in the paediatric population will be discussed in both sessions.

The workshop programme is published in September. This is an in-person attendance event. 

Registration

• Registration opens in mid-September

Initially, registration will be open to representatives of organisations which have provided comments on the concept paper during the public consultation; for the remaining seats, registration will be open to all. 

In-person attendance is essential to participate actively in the workshop. The event is also live broadcast.