Learning objectives
Aspirants willing to know the Eu regulations, submission procedures, Module 1 specific to Eu & Variation filing. Session has been recorded by IPM associate who is an Europe Subject Matter Expert
Eligibility
B. Pharm / M. Pharm / M. Sc. / anyone willing to understand the EU formulation regulatory submission
Syllabus
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Section 1:
6.5 hrs
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- Part 1 [Introduction to EU agencies, EU terms, Marketing Authorization Procedures introduction and EU patents] 128 minutes
- Part 2 [Centralized procedure, National procedure, MRP & DCP] 80 minutes
- Part 3 [EU Dossier Module 1,2 and Brexit, UK] 75 minutes
- Variations 80 minutes