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Good Clinical Practice

Good Clinical Practice
 Hotel Crown Plaza, Rohini, Delhi - 110085 Jul 28 - Jul 28, 2018 Past

Good Clinical Practice

Current regulatory and ethical requirements for conducting clinical trials/research in India. Rajiv Gandhi Cancer Institute and Research Centre, Delhi July 28, 2018.

 

 

                                               Program Agenda

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
Director Training, CDSA, THSTI, DBT

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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