Event
Department Of Pharmacology
A Webinar on Good Clinical Practice (GCP) and New Drugs and Clinical Trial Rules, 2019 (NDCTR)
A Webinar on Good Clinical Practice (GCP) and New Drugs and Clinical Trial Rules, 2019 (NDCTR) for Clinicians, Researchers and Ethics Committee Members was organized by Department of Pharmacology
Dates: 12/10/2020 and 13/10/2020
Number of participants: 65
MMC sanctioned 04 credit points for this Webinar.
MMC Observer: Dr. Pradeep Khinvasara [MMC Code: MMC/MAO-00965/2016]
Organizing Chairperson: Dr. Uma Bhosale (Professor & Head Pharmacology/Member secretary IEC, SKNMCGH)
INTRODUCTION
Clinical research is the key to the discovery of latest diagnostic methods and to develop modern drugs for treatment of diseases. Good Clinical Practices (GCP) is an ethical and scientific quality standard for designing, conducting and recording trials that involve the participation of human subjects. Compliance with this standard provides assurance to public that the rights, safety and well being of trial subjects are protected, consistent with the principles enshrined in the Declaration of Helsinki and ensures that clinical trial data are credible.
Therefore it is mandatory for all clinicians, researchers and EC members to undergo Good Clinical Practice (GCP) training and to know the schedules and chapters included in New Drugs and Clinical Trial Rules, 2019 (NDCTR) for conducting Clinical Trials in India. This Webinar was considered as an opportunity to get well versed with all guidelines regarding new rules passed by DCGI in March 2019 for conducting Clinical Trials and Clinical research.