1. Regulatory Mechanism in Clinical Trials Convention Hall, SIU Lavale

2. Name of the Speaker: Dr. Raman Gangakhedkar Designation: Deputy Director, NARI Topic: Regulatory Mechanism in Clinical Trials

3. SUMMARY Sir started the presentation by giving examples of regulatory bodies At National level Drug Controller General of India (DGCI) Clinical Trial Registry of India ICMR At Institutional level Scientific advisory committee Independent ethics committee

4. What is changing now ? Consent procedures SAE (Serious Adverse Event Reporting) Ethics Committee Compensation Rules IND Drugs have to undergo all phases of trial First time generics need bridging studies Documents of IEC approval : Study protocol & informed consent template Patient information material & advertisement Letters of amendment

5. Guidelines : Milestones 1996 – ICH Guidelines 2000 – ICMR Guidelines 2001 – Indian GCP Guidelines 2003 – Revision of BE Guidelines 2003 – Revision of schedule Y 2013 – New DCGI Guidelines

6. Report Prepared By: Akhila Nayak Anisha Mehta Ebrahim Khan Nikhil Dhorepatil Shirin Khan Swati Sonik Yogita Patil (MBA –HHM 2013-15)