Port Blair, May 11: The 4 day CME (Continuous Medical Education) on Research Methodology, Good Clinical Practice and Current Ethical & Regulatory Requirements for Clinical Trial/Research organized by Andaman & Nicobar Islands Institute of Medical Sciences (ANIIMS), Port Blair in collaboration with Clinical Development Services Agency (CDSA) concluded on Tuesday. The CME program was inaugurated by the Chief Secretary, Mr Anindo Majumdar on May 7 during which he praised the efforts made by ANIIMS and CDSA in organizing the program and said that this type of program should be conducted on regular basis which is necessary for institute like ANIIMS being in its growing stage. This was the 70th CME organized by CDSA in India and was first in Andaman & Nicobar Islands.
Eminent speakers from Clinical Development Services Agency (CDSA) of various disciplines including Dr. Y.K. Gupta, Professor & HOD, Pharmacology, AIIMS, New Delhi, Dr. J.P. Muliyil, Former Principal, CMC, Vellore, Dr. G.K. Singh, Director, AIIMS, Patna, Dr. Bikash Medhi, Professor of Pharmacology, PGIMER, Chandigarh, Ms Nandini K. Kumar, Former Deputy Director, ICMR, Dr. Sudhakar Bangera, COO & Program Director, CDSA, Dr. Sucheta Banerjee, Director Training, CDSA, Dr. Gayatri Vishwakarma, Biostatistician, CDSA, New Delhi, Mrs. Nagalakshmi, CEO, Consortium Clinical Research, Coimbatore facilitated case studies and discussions. Dr. Y.K. Gupta presented a special session on Pharmaco vigilance and stressed the need for reporting the adverse drug reactions (ADR) to the regulatory authority.
The first two days focused on Research Methodology which included topics like Research Hypothesis, Study Designs, Sample Size Calculation, Manuscript Writing, etc. Third day was dedicated to Good Clinical Practice and included topics like Ethical Considerations, Requirements of Clinical Trials, Record Keeping & data Handling, Roles & Responsibilities of Sponsors, Investigator and Monitor. Fourth day was dedicated to Current Ethical & Regulatory Requirements for Clinical Trial/Research and included topics like ICMR Ethical Guidelines for Biomedical Research, Ethics Committee, Informed Consent Process, SAE Causality Assessment & Compensation and Conflict of Interest.
The Director, ANIIMS, Maj. Gen. R P Choubey (Retd.) thanked the expert faculties for sharing their valuable knowledge with the participants. He also thanked the participants for their overwhelming participations in all the sessions including the interactive sessions. He also praised the efforts of the Organizing Team for making this event successful. Specially designed certificate of participation by CDSA were given to those participants only who attended the pre & post lunch sessions and participated in exit assessment process. In addition, all the participants will also be given certificate issued by Tamil Nadu Medical Council, assigning 8 credit hours.
