Learning objectives
Eligibility
B.Pharm/M.Pharm/M.Sc/B.Sc/MBA/ PhD/ Working professionals from Pharma/Bio-tech industry [QC/QA/R & D/F & D/ ADL/ RA/ Patents/International business etc] & those aspiring to enhance their regulatory affairs knowledge.
Anyone willing to understand this topic can enroll.
Syllabus
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Section 1: Eu agencies, Marketing authorization procedures, Patents, Submission modules, variation filing
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- Introduction to Eu agencies, Marketing authorization procedures 97 minutes
- Centralized procedure, National procedure, MRP & DCP 93 minutes
- Eu Patents 32 minutes
- Variations 35 minutes
- Eu Module 1 & Module 2 115 minutes