Description
Scientific advice and marketing authorisation assessments for human medicines with focus on oncology
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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
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