Regulatory affairs/ regulatory requirements for drug approval

Introduction, Regulatory Affairs Historical Overview, Regulatory Authorities, Regulatory Affairs Department Role, and Regulatory Affairs Professionals' Responsibilities. Regulations needed to approve a drug: Clinical research / BE studies, Clinical Research Protocols, Biostatistics in Pharmaceutical Product Development, Data Presentation for FDA Submissions, Pharmacology, Drug Metabolism and Toxicology, Non-Clinical Drug Development, Pharmacology, Investigational New Drug (IND) Application, Investigator's Brochure (IB) and New Drug Application (NDA), and Management of Clinical Studies.
Keywords: Drug Approval, Clinical Research, Investigational New Drug (IND), New Drug Application (NDA), Biostatistics