Certificate
Course completed by
Mr. Ayanava Hazra
Course Duration
~ 1 hour
Issued
15/06/2023
Certificate ID
56c850291e633be7
Skills
Importance of Regulatory affairs. Major regulations governing pharmaceuticals. Drug Discovery & Development process. Pre-clinical & Clinical studies. Submission process of IND, NDA, ANDA & BLA Applications. Types of Drug Master Files. Structure and organisation of Common Technical Documents. Concepts of Code of Federal Regulations & Federal Register. Significance of Orange & Purple Book. Activities of Pharmacovigilance & Post-Marketing Surveillance. Case studies depicting the importance of the regulatory affairs.