EMA and the Heads of Medicines Agencies (HMA) are collaborating to help oncology scientists participate in medicine regulation.
EMA is also supporting the United States (US) Food and Drug Administration (FDA) in its efforts to improve awareness and understanding of oncology product development.
For more information on cancer medicines, see:
EMA and the Heads of Medicines Agencies (HMA) completed a pilot project enabling clinical-oncology scientists to participate in medicine regulation.
The pilot aimed to provide them with an understanding of basic principles relevant to their field.
It focused on scientific advice and marketing authorisation assessments for human medicines.
It consisted of live and recorded webinars covering the following areas:
For any questions, please contact:
ema_hma_pilot_educational_program_oncology@ema.europa.eu
To view the recorded webinars, please follow the link below:
The pilot aligned with the recommendations of the STARS common strategy.
It ran between September 2023 and June 2024.
EMA regularly exchanges information with FDA on oncology related projects, including those of an educational nature.
One example is Project Socrates. It aims to provide insight and boost transparency on the role of FDA in oncology product development.
FDA's Oncology Centre of Excellence (OCE) runs this project.
More widely, EMA has been collaborating with FDA on the non-clinical oncology cluster since 2014, and on the oncology-haematology cluster since 2004. For more information, see Cluster activities.