Inovocare Healthsoft Solutions, Kolkata

Inovocare e-Academy GCP Training Programme

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

14. Take Home Messages 5 min

Registration Link: https://forms.gle/dzEWv2cNEuB4BqJB7

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