Schedule : 15-16 September, 2021 Fees : Rs. 1,500 per head Sr. No. Sessions – Day One Duration
1. Welcome and Opening Comments 5 min
2. Good Clinical Practice - History and Evolution, Definition, 30 min L +
Principles 10 min QA 3. Clinical Drug Development and Pre-Licensure Clinical Trials - 25 min L + Regulatory Perspectives in India 15 min Discussion 4. Clinical Trial Operations and Management, Trial Conduct 30 min L + Steps and Activities at Site 10 min Discussion 5. Ethics in Clinical Research - Principles, Committee, Review 35 min L + Process, Role of Individual Members, Informed Consent 10 min Discussion 6. Quality Assurance in Clinical Trials Operations - Role of Site 25 min L + Monitoring and Audit 10 min QA 7. Summary of Day's Proceedings 15 min
Sr. No. Sessions – Day Two Duration
8. Lessons Learnt on Day One 10 min
9. Role of Sponsor and Regulatory Perspectives in Clinical 35 min L + 10 min
Trials Conduct Discussion 10. Participant Safety Considerations - Serious Adverse Event 35 min L + Reporting and Management, Compensation Issues 10 min Discussion 11. Clinical Research in Covid Pandemic Times 20 min L
12. Academic Clinical Research and ICMR Ethics Guidelines 35 min L +
10 min Discussion 13. Summary of Day's Proceedings and Discussion 15 min