Post Graduate Diploma in Drug Regulatory Affairs Syllabus 2025: Subjects, Specializations, and Semester-wise Syllabus

Syllabus & Subjects of Post Graduate Diploma in Drug Regulatory Affairs  

A Post Graduate Diploma in Drug Regulatory Affairs is a specialized program designed to equip students with in-depth knowledge and practical skills in navigating the complex regulatory landscape of the pharmaceutical industry. In the first semester, students delve into foundational concepts, starting with an introduction to Drug Regulatory Affairs. This module provides an overview of regulatory agencies and their pivotal roles, alongside a historical context of drug regulation. Additionally, international harmonization efforts are explored, highlighting the global nature of drug approval processes.The second module of the first semester focuses on Pharmaceutical Legislation and Compliance. Here, students delve into the intricacies of both national and international pharmaceutical laws, gaining a comprehensive understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP). These critical components of pharmaceutical quality assurance are essential for ensuring the safety and efficacy of drugs. Moving into the second semester, the curriculum delves deeper into critical areas of drug development. The Drug Development Process module covers the various phases, from pre-clinical to clinical development, culminating in key milestones like the Investigational New Drug (IND) application and the New Drug Application (NDA). Understanding these processes is fundamental for professionals working in regulatory affairs, as they play a pivotal role in shepherding drugs from concept to market.

Syllabus of Post Graduate Diploma in Drug Regulatory Affairs