Module 1 – Introduction to Drug Regulatory Affairs

Module 2 – CTD and eCTD Dossier Preparation: Structure, Content, and Practical Workflow

Module 3- Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP): Foundations of Quality and Compliance

Module 5 – Regulatory Strategy and Lifecycle Management: Sustaining Compliance and Market Success

Module 6 – Biotechnological Product Regulation and Biosimilar Approval Pathways

Module 7 – Ethics, Data Integrity, and Digital Transformation in Regulatory Affairs

Module 8 – Future Trends in Drug Regulation: AI, Real-World Evidence, and Global Harmonization

Final Quiz