Learning objectives
Knowledge of the following topics:
3.2.S Drug Substance: 3.2.S.1 General Information, 3.2.S.2 Manufacture, 3.2.S.3 Characterisation, 3.2.S.4 Control of Drug Substance, 3.2.S.5 Reference Standards or Materials, 3.2.S.6 Container Closure System, 3.2.S.7 Stability
3.2.P Drug Product: 3.2.P.1 Description and Composition of the Drug Product, 3.2.P.2 Pharmaceutical Development, 3.2.P.3 Manufacture, 3.2.P.4 Control of Excipients, 3.2.P.5 Control of drug product, 3.2.P.6 Reference Standards or Materials, 3.2.P.7 Container Closure System 3.2.P.8 Stability
3.2.A Appendices, 3.2.R Regional Information, 3.3 Literature References
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: Module 3 Drug substance & drug product sections
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- ICH M4Q CTD format introduction 45 minutes
- Module 3 Drug substance sections S.1, S.2, APISM, ICHQ11 reference 150 minutes
- Module 3 Drug substance sections S.3, S.4, S.5 80 minutes
- Module 3 Drug substance sections S.6, S.7 36 minutes
- Module 3 drug product sections P.1, P.3, P.4 90 minutes
- Module 3 drug product sections P.2 75 minutes
- Module 3 drug product sections P.5, P.6, P.7, P.8 166 minutes
- Module 3 drug product sections 3.2.R & 3.2.A 24 minutes