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Fundamentals of EU Regulatory Affairs

4-week online academy | 2 hours per week

3 - 31 August 2020

Online Academy

Course Content Summary

1. Overview of EU regulatory framework
2. Product development: non-clinical studies
3. Product development: clinical studies
4. Marketing Authorisation 1/3: the regulatory procedures
5. Marketing Authorisation Application 2/3: the registration dossier
6. Marketing Authorisation Application 3/3: labelling and packaging requirements
7. Post-MAA: filing variations and renewals
8. Post-MAA: Pharmacovigilance obligations