Regulatory Affairs (Theory)

Fundamentals of Regulatory Affairs Introduction to Drug Regulatory Affairs, Overview of regulatory authorities in India and major international markets (US FDA, EMA, PMDA), Role and responsibilities of Regulatory Affairs Professionals, Organizational structure of regulatory bodies. Basic regulatory terminologies: Guidance, Guidelines, Regulations, Laws, Acts. Regulatory reference resources: Orange Book, Purple Book, Federal Register, Code of Federal Regulations (CFR).

Regulatory Requirements in Drug Development Drug discovery and development process, Drug development teams and their functions. Non-clinical drug development: Pharmacology, Drug metabolism, Toxicology. Regulatory documentation: Investigational New Drug (IND) protocols, Biostatistics in pharmaceutical product development, Bioequivalence (BE) studies, Data presentation for regulatory submissions.

Indian Regulatory Framework and Approval Process Central Drugs Standard Control Organization (CDSCO) and State Licensing Authorities: Organization and responsibilities, Regulatory requirements for import, manufacture, and sale of pharmaceuticals in India, Certificate of Pharmaceutical Product (COPP), Regulatory approval procedure for new drugs in India, Clinical trial regulatory requirements in India, phytopharmaceutical regulations, Good Clinical Practice (GCP) guidelines and Schedule Y, Innovator and generic drugs, Generic drug product development Phytopharmaceutical regulation by AYUSH and CDSCO.

Types of regulatory applications: Investigational New Drug (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA) Drug Master Files (DMF), Common Technical Document (CTD), electronic CTD (eCTD), ASEAN CTD (ACTD), Registration procedure for Indian drug products in overseas markets, Post-approval changes to NDA and ANDA.

Clinical research phases (I-IV), Clinical trial documents, Institutional Review Board (IRB) and Independent Ethics Committee (IEC): Formation and functions Informed consent process and documentation, Good Clinical Practice (GCP) obligations of investigators, sponsors, and monitors, Management and monitoring of clinical trials, Pharmacovigilance: Safety monitoring during clinical trials and post- marketing,