Good Clinical Practice (GCP) and NDCT (New Drugs and Clinical Trials)
04th January, 2021 & 05th January, 2021
Index Medical College, Hospital and Research Center (Malwanchal University)organized and conducted a Workshop on Good Clinical Practice (GCP) and NDCT (New Drugs and Clinical Trials).
This workshop aimed at training the participants about the ethics, rules, regulations, roles and responsibilities of various stake holders in the development and study ofdrugs as per the standards of NABH (National Accreditation Board for Hospitals and Health Care)and ICMR guidelines.
The workshop deliberated on the following topics:
Overviews of Good Clinical Practice – Definition and Evolution, Principles of GCP
CDSCO, WHO and ICH
Prospects of Clinical Trialsand Biomedical Health Research in India
Roles and responsibilities of stake holders (sponsors, investigators and regulators), informed consent, confidentiality, privacy, vulnerable populations, ethical considerations
EC/IRB members and their roles and responsibilities, safety consideration in CR
Documentation, data handling and record keeping, monitoring, audit and inspection in Clinical Trials and NDCT Rules 2019.
The awareness and understanding of all these topics were emphasized to be a vital component of Medical Sciences.
Dr.Prem Nyati, Dr. Suraj Tripathi and Dr.Aarti S. and Ms. Deepshikha were the facilitator of the workshop.
The workshop was attended by 44 participants from different Medical and Dental Departments as well as the expert non-affiliated members of various Ethics Committees.
The event was graced by the presence of:
Shri Suresh Singh Bhadoria (Chairman, Mayank Welfare Society – Index Group of Institutions, Malwanchal University)
Shri N.K.Tripathi (Vice Chancellor, Malwanchal University)
Dr. Ram Ghulam Rajdan (Pro-Vice-Chancellor, Malwanchal University)
Dr. G.S. Patel (Dean, Index Medical College, Hospital and Research Center [IMCHRC])
Dr S. Karandikar (Dean, Index Institute of Dental Sciences [IIDS])
Dr. B.K.Agrawal(PG Director)
Dr. D.K.Taneja(Chairperson, IEC)
Dr. B.M. Shrivastav(Chairperson, IEC, IIDS)
Dr K.K.Saxena(Chairperson of IEC, MU)
Dr.Mrs.P.Taneja, Dr.Rajni Bhandari, Dr.Snehlata Upadhyay, Mr.K.S.Thakur, Mr.Hemandra Jain (Members of ECs)
Severalsenior teaching faculty of Index Group of Institutions (Malwanchal University)
The workshop followed the COVID-19 safety measure normsand the study material and the contents of entire lectures were provided in eco-friendly electronic manner.
The key for the pre and post tests were also posted in whatsapp group of the workshop. Evaluation analysis of both the tests (posted in the group) reflected a huge positive change in the concepts of the participants.
