Course Outline - Regulatory Writing

Duration: 30 days

1. Module 1: Introduction to Regulatory Affairs.
• Importance of regulatory compliance.
• Overview of pharmaceuticals, biologics, medical devices, nutraceuticals.
2. Module 2: Global Regulatory Authorities.
• Roles of USFDA, EMA, and Indian agencies (CDSCO, DCGI).
• Comparative study of regulatory frameworks
3. Module 3: International Harmonisation Initiatives.
• ICH, PIC/S, CTD, eCTD.
• Benefits of global harmonisation.
4. Module 4: Indian Regulatory Framework.
• CDSCO & DCGI structure.
• Schedule Y and the drug approval process.
5. Module 5: US Regulatory Framework.
• FDA organisation and functions.
• IND, NDA, ANDA, BLA pathways.
6. Module 6: EMA Regulatory Framework.
• EMA committees and structure.
• Centralised, Decentralised, and Mutual Recognition procedures.
7. Module 7: Common Technical Document (CTD & eCTD).
• CTD modules and structure.
• Global submission process and eCTD.
8. Module 8: CMC Documentation.
• Module 3 CTD preparation.
• Manufacturing, quality, and stability data.
9. Module 9: Biosimilars Regulation.
• EMA and USFDA biosimilar guidelines.
• Comparability studies and pharmacovigilance.
10. Module 10: Biologics Regulation.
• Regulatory process in India, US, and EMA.
• Stability studies and post-approval requirements.
11. Module 11: Medical Devices Regulation (India, US, EU).
• Device classifications.
• ISO 13485, CE Marking, USFDA device pathways.
12. Module 12: Veterinary Products Regulation.
• India and US frameworks.
• Documentation and approval pathways.
13. Module 13: Nutraceuticals and Food Supplements.
• Regulatory documentation requirements.
• Labelling and health claims compliance.
14. Module 14: IND & NDA Requirements.
• IND filing process (India & US).
• NDA dossier structure and requirements.
15. Module 15: ANDA & Generic Drug Filing.
• Para IV certifications.
• Bioequivalence studies and approvals.
16. Module 16: Drug Master File (DMF) Preparation.
• DMF types and structure (India & US).
• Lifecycle management and submissions.
17. Module 17: Site Master File (SMF) Preparation.
• SMF content and inspections.
• Global compliance requirements.
18. Module 18: New Drug Approval Lifecycle.
• NDA/BLA dossier structure (India & USFDA).
• EMA Marketing Authorisation Applications (MAA).
19. Module 19: Post-Approval Changes & Lifecycle Management.
• Variations, renewals, and market compliance.
20. Module 20: Strategic Regulatory Planning.
• Market entry strategy (US, EU, India).
• Dossier planning and timelines.
21. Module 21: Regulatory Communications.
• Writing effective responses to authority queries.
• Regulatory writing best practices.
22. Module 22: Corporate Communication & Documentation.
• Internal communication with R&D, QA, and CMC teams.
• Preparing for regulatory inspections.
23. Module 23: Case Study – India vs US vs EU.
• Comparison of submission processes.
• Common challenges and solutions.
24. Module 24: Case Study – ANDA vs Biosimilars.
• Strategic differences in approval processes.
• Risk management and documentation.
25. Module 25: Final Review & Certification.
• Consolidation of all modules.
• Mock submission strategy.
• Assessment and certification.