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The unit-wise syllabus below is complete, so you can still plan what to study.
THEORY 1.
a.
Documentation in Pharmaceutical industry: Master formula record, DMF (Drug Master File), distribution records.
Generic drugs product development Introduction , Hatch- Waxman act and amendments, CFR (CODE OF FEDERAL REGULATION) ,drug product performance, in-vitro, ANDA regulatory approval process, NDA approval process, BE and drug product assessment, in –vivo, scale up process approval changes, post marketing surveillance, outsourcing BA and BE to CRO.
b.
Regulatory requirement for product approval: API, biologics, novel, therapies obtaining NDA, ANDA for generic drugs ways and means of US registration for foreign drugs Hrs CMC, post approval regulatory affairs. Regulation for combination products and medical devices.CTD and ECTD format, industry and FDA liaison. ICH - Guidelines of ICH-Q, S E, M. Regulatory requirements of EU, MHRA, TGA and ROW countries.
Non clinical drug development: Global submission of IND, NDA, ANDA. Investigation of medicinal products dossier, dossier (IMPD) and investigator brochure (IB).
Clinical trials:
Developing clinical trial protocols. Institutional review board/ independent ethics committee Formulation and working procedures informed Consent process and procedures.
HIPAA- new, requirement to clinical study process, pharmacovigilance safety monitoring in clinical trials.
Hrs Hrs Hrs
As per the latest IPU syllabus — cross-check electives with your college.
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Regulatory Affairs (MPH104T) is a semester 1 subject in the IPU M.Pharm M.Pharm (Pharmaceutics) (M.Pharm (MPH)) curriculum.
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