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Regulatory Mechanism in Clinical Trials Convention Hall, SIU Lavale

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.

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Regulatory Mechanism in Clinical Trials Convention Hall, SIU Lavale

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  1. Regulatory Mechanism in Clinical TrialsConvention 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: • AkhilaNayak • Anisha Mehta • Ebrahim Khan • Nikhil Dhorepatil • Shirin Khan • Swati Sonik • YogitaPatil (MBA –HHM 2013-15)

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