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

  1. Dr. P Rama Mohan DM, Professor of Pharmacology, Narayana Medical College, Nellore, AP
  2. Dr. Venkata Kishan DM, Senior Manager R&D, Sanzyme (P) Limited, Hyderabad- TG
  3. Dr. C. Prabhakar Reddy DM, Associate Professor of Clinical Pharmacology & Therapeutics, Nizam’s Institute of Medical Sciences, Hyderabad, TG
  4. Dr. B. Madhavulu MD, Professor of Pharmacology, Narayana Medical College, Nellore, AP

 

SCHEDULE FOR ICH/GCP TRAINING PROGRAM

09.30 AM – 09.45 AM

Registration

 

09.45 AM – 10.00 AM

Inauguration

 

10.00 AM – 10.30 AM

Overview of CDSCO vision for approval of ethics committee

Dr. B Madhavulu

10.30 AM – 11.00 AM

Introduction & Principles of GCP

Dr. C. Prabhakar Reddy

11.00 AM – 11.30 AM

Clinical Trial Protocol & Essential Documents & Its amendments

Dr.  P. Venkata Kishan

11.30 AM-12.00 PM

Informed Consent

Dr. C. Prabhakar Reddy

12.00 PM – 12.30 PM

Authorities IEC and their responsibilities IEC Review Process-
Investigator and IEC Interactions

Dr. P Rama Mohan 

12.30 PM – 01.00 PM

Investigator, Sponsor’s & Monitors Responsibilities

Dr. P. Venkata Kishan

01.00 PM – 02.00 PM

 Lunch 

 

02.00 PM – 02.45 PM

Safety & Adverse Event Reporting

Dr. P. Venkata Kishan

02.45 PM – 03.15 PM

Compensation to Research Participant

Dr. C. Prabhakar Reddy

03.15 PM – 03.45 PM

Monitoring and Record Keeping

Dr. P. Venkata Kishan

03.45 PM-04.00 PM

 Discussion and vote of thanks

Dr. P Rama Mohan

 

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