Regulatory Mechanism in Clinical Trials

Convention Hall, SIU Lavale

Name of the Speaker: Dr. Raman Gangakhedkar

Designation: Deputy Director, NARI

Topic : Regulatory Mechanism in Clinical Trials

SUMMARY• Sir started the presentation by giving examples of

regulatory bodies

• At National level Drug Controller General of India (DGCI)Clinical Trial Registry of IndiaICMR

• At Institutional levelScientific advisory committeeIndependent ethics committee

What is changing now ?Consent proceduresSAE (Serious Adverse Event Reporting)Ethics CommitteeCompensation RulesIND Drugs have to undergo all phases of trialFirst time generics need bridging studies

Documents of IEC approval :Study protocol & informed consent templatePatient information material & advertisementLetters of amendment

Guidelines : Milestones1996 – ICH Guidelines2000 – ICMR Guidelines2001 – Indian GCP Guidelines2003 – Revision of BE Guidelines2003 – Revision of schedule Y2013 – New DCGI Guidelines

Report Prepared By:

• Akhila Nayak

• Anisha Mehta

• Ebrahim Khan

• Nikhil Dhorepatil

• Shirin Khan

• Swati Sonik

• Yogita Patil

(MBA –HHM 2013-15)