Good Clinical Practice workshop for research review committees of Narayana Medical, Dental and Nursing Colleges, Nellore, AP
It is mandatory for all the institutional ethics committees to register with CDSCO (CENTRAL DRUGS STANDARD CONTROL ORGANIZATION), which is a Governmental organization, works under the ministry of health. Members of the Ethics committee should undergo this training program on ICH to maintain good clinical practice guidelines and also schedule Y guidelines to review research proposals. This program was conducted at Narayana Medical College, which was organised by department of Pharmacology on 26/08/2018 (Sunday) in anatomy Demo-1 from morning 9.30 AM to 4.00 PM.
50 IEC members were participated in this training session.
The following resource persons gave training to the participants
- Dr. P Rama Mohan DM, Professor of Pharmacology, Narayana Medical College, Nellore, AP
- Dr. Venkata Kishan DM, Senior Manager R&D, Sanzyme (P) Limited, Hyderabad- TG
- Dr. C. Prabhakar Reddy DM, Associate Professor of Clinical Pharmacology & Therapeutics, Nizam’s Institute of Medical Sciences, Hyderabad, TG
- Dr. B. Madhavulu MD, Professor of Pharmacology, Narayana Medical College, Nellore, AP
SCHEDULE FOR ICH/GCP TRAINING PROGRAM
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09.30 AM – 09.45 AM |
Registration |
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09.45 AM – 10.00 AM |
Inauguration |
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10.00 AM – 10.30 AM |
Overview of CDSCO vision for approval of ethics committee |
Dr. B Madhavulu |
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10.30 AM – 11.00 AM |
Introduction & Principles of GCP |
Dr. C. Prabhakar Reddy |
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11.00 AM – 11.30 AM |
Clinical Trial Protocol & Essential Documents & Its amendments |
Dr. P. Venkata Kishan |
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11.30 AM-12.00 PM |
Informed Consent |
Dr. C. Prabhakar Reddy |
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12.00 PM – 12.30 PM |
Authorities IEC and their responsibilities IEC Review Process- |
Dr. P Rama Mohan |
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12.30 PM – 01.00 PM |
Investigator, Sponsor’s & Monitors Responsibilities |
Dr. P. Venkata Kishan |
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01.00 PM – 02.00 PM |
Lunch |
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02.00 PM – 02.45 PM |
Safety & Adverse Event Reporting |
Dr. P. Venkata Kishan |
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02.45 PM – 03.15 PM |
Compensation to Research Participant |
Dr. C. Prabhakar Reddy |
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03.15 PM – 03.45 PM |
Monitoring and Record Keeping |
Dr. P. Venkata Kishan |
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03.45 PM-04.00 PM |
Discussion and vote of thanks |
Dr. P Rama Mohan |
