Current regulatory and ethical requirements for conducting clinical trials/research in India. Rajiv Gandhi Cancer Institute and Research Centre, Delhi July 28, 2018.
| Time | Title (Learning Objectives) | Presenter |
|---|---|---|
| 08:30 – 09:00 | Registration |
Ms. Vandana Chawla& RGCI&RC Team Training Manager, CDSA, THSTI, DBT |
| 09:00 – 09:30 | Welcome Address Course Introduction & Overview Vote of Thanks |
·Dr. Sudhir Rawal Medical Director, Rajiv Gandhi Cancer Institute and Research Centre (RGCI&RC) Dr. Sucheta Banerjee Kurundkar Director Training, CDSA, THSTI, DBT Dr. S. Avinash Rao Convener IRB & Director Radiology, RGCI&RC |
| 09:30 – 10:15 |
Good Clinical Practice (GCP) What is GCP? Why GCP? Principles of GCP CDSCO, ICH E6 R2, WHO |
Dr. Sucheta Banerjee Kurundkar |
| 10:15 – 11:00 | Current regulatory requirements for conducting clinical trials/research in India Preparing for audit & regulatory inspection |
Shri. A. B. Ramteke Former Joint Drugs Controller (India), CDSCO, HQ, New Delhi; Consultant, Regulatory Affairs, CDSA, THSTI, DBT |
| 11:00 – 11:15 | Tea/Coffee Break | |
| 11:15 – 12:00 | National ethical guidelines 2017 | Dr. Nandini K. Kumar Former Deputy Director General (Senior Grade), ICMR; Adjunct Faculty, CDSA, THSTI, DBT |
| 12:00 – 12:45 | Current ethical requirements for conducting clinical trials/research in India | Dr. Nandini K. Kumar Former Deputy Director General (Senior Grade), ICMR; Adjunct Faculty, CDSA, THSTI, DBT |
| 12:45 – 13:30 | Roles and Responsibilities of stakeholders: Sponsor, Institution, Investigator | Dr. Monika Bahl Director Clinical Portfolio Management, CDSA, THSTI. DBT |
| 13:30 – 14:15 | Group Photograph followed by Lunch | |
| 14:15 – 14:45 | Monitoring clinical trials managing CRO oversight to comply with GCP | Dr. Monika Bahl Director Clinical Portfolio Management, CDSA, THSTI. DBT |
| 14:45 – 15:15 | Record Keeping and Data Handling | Dr. Monika Bahl Director Clinical Portfolio Management, CDSA, THSTI. DBT |
| 15:15 – 15:30 | Tea/Coffee Break | |
| 15:30 – 16:00 | Quality Assurance | Dr. Sucheta Banerjee Kurundkar Director Training, CDSA, THSTI. DBT |
| 16:00 – 16:45 | NABH accreditation | Dr. Sucheta Banerjee Kurundkar Director Training, CDSA, THSTI. DBT |
| 16:45 – 17:30 | Exit Assessment | Participants |
| 17:30 | Open Forum for Q & A; Feedback; Distribution of Certificates | |
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