Module 6

04 October 2024

An Agency perspective: the success and failure of a medicinal product in the EU

Msc Module 6 - Lecture 5: Regulatory Strategy; From Development to the Market Place

Presented by Gaelle Andriantafika on 8 October 2024 Senior Scientific Specialist, Therapeutic Areas Department, Human Division

An agency of the European Union

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Learning Outcomes

• Define and critically debate the strategic regulatory issues likely to arise during the development phases of a medicinal product to provide effective advice to applicants as necessary. • Define key challenges and criteria for success when assessing a MAA (NCE, new dosages, new indications) in order to help applicants recognise the essential needs for submission readiness.

An Agency perspective: the success and failure of a medicinal product in the EU

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Classified as public by the European Medicines Agency

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