Italian Medicines Agency Agenzia Italiana del Farmaco

Enabling oncology scientists' participation in medicine regulation (pilot project) (new) - Enabling oncology scientists' participation in medicine regulation (pilot project) (new)

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Enabling oncology scientists' participation in medicine regulation (pilot project) (new)

EMA and the Heads of Medicines Agencies (HMA) are running a pilot project to enable clinical-oncology scientists to participate in medicine regulation. The pilot aims to achieve this by providing them with an understanding of basic principles relevant to their field.

The pilot focuses on scientific advice and marketing authorisation assessments for human medicines.

Prospective candidates must have experience in clinical oncology or haemato-oncology.
They do not need to have any prior understanding of regulatory requirements in medicine evaluation.

The pilot consists of live and recorded webinars covering the following areas:
•    Basic principles of the regulation of human medicines in the EU
•    Basic regulatory aspects relevant to oncology

Prospective candidates can apply by completing a brief registration form.

Participation is free of charge.

EMA and HMA launched the pilot in May 2023. It will be rolled out over 12 months.
It aims to increase collaboration between regulatory authorities and stakeholders in healthcare and academia, in line with the recommendations of the STARS common strategy.


Published on: 05 June 2023

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