Event
Department Of Pharmacology
Workshop on Good Clinical Practice (GCP) and New Drugs and Clinical Trial Rules, 2019 (NDCTR)
A Physical Workshop on Good Clinical Practice (GCP) and New Drugs and Clinical Trial Rules, 2019 (NDCTR) was successfully conducted by Dept. of Pharmacology for Post graduate Residents (JR1) of SKNMC, Pune
Date of GCP Workshop: 12/09/2022 and 13/09/2022
Venue: MET hall, SKNMC, Pune
Number of participants: 82
Organizing Chairperson: Dr. Uma Bhosale (HOD, Pharmacology/ Member secretary IEC, SKNMCGH)
Moderator: Dr Manisha Varushney
Speakers:
Dr Uma Bhosale Dr Yogita Karandiakar
Dr Shahu Ingole Dr Vinod Shinde
| GCP Workshop Agenda | Speaker | Time |
| Opening Address | Dr Krishnakant Patil Dean SKNMC | 9:30 – 9:45 |
| GCP Principles | Dr Uma Bhosale | 9:45 – 10:45 |
| Clinical Trials | Dr Shahu Ingole | 10:45 – 11:45 |
| New Drug and Clinical Trial Rules 2019 | Dr Vinod Shinde | 11:45 – 12:30 |
| Pharmacovigilance and Rational Therapeutics | Dr Yogita Karandikar | 12:30 – 13:00 |
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.
Postgraduate students are required to conduct clinical research as a part of their Thesis as per their post graduate curriculum and also will be collaborating with researchers for their departmental research. Moreover, these tomorrow’s Postgraduate doctors will be contributing significantly in future to the research done in their respective field once they start their clinical practice. Therefore, it is mandatory for PG residents 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 GCP Workshop was actively attended by 80 Resident Doctors (JR1) of various departments. Clinical research related queries were solved at the end of each session by the experts. Certificates of participation were handed over to all the participants.
