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Workshop on “Good Clinical Practices and Good Laboratory Practices”

Workshop on “Good Clinical Practices and Good Laboratory Practices” was organized by Dept. of Pharmacology, KBN University FOMS, on 26/08/2024, from 9:00am to 5:00 pm in the Lecture Hall of Dept. of Forensic Medicine. 24 post graduate students, 7faculty members from various departments of FOMS participated in the workshop. The list of all the participants is enclosed with this report. Also please find the agenda attached with this report

The speakers for the workshop were:

Dr. Anuradha HV, Professor & Head, Dept. of Pharmacology, MS Ramaiah Medical College, Bengaluru, Dr. Zainab Ghazala, Associate Professor, Dept. of Pharmacology, KBN University- FOMS, Dr. Zeenath Begum, Professor, Dept. of Pathology, KBN University- FOMS


The participants gained insights into the ethical aspects of clinical research by learning about the latest changes made in the ICH-GCP guidelines and they were made aware about the various aspects of national ethical guidelines for conduct of biomedical health research.


The valedictory function was attended by Dean (FOMS) Dr. Siddesh Sirwar and Director IQAC/Deputy controller of examination Dr. M.A Baseer, Dean of Research, Dr. Rajshree Paladi, Medical Superintendent, KBNTGH, Dr. Siddling Chengte. Dr. Zainab Ghazala welcomed the dignitaries and highlighted the important events of the workshop.


The speakers were felicitated and certificates were distributed to all the participants. The workshop concluded by vote of thanks by Dr. S.H Vardhamane.



Agenda

Time

Topic

Speaker

8:30 am - 9:00 am

Registration

9.00 am - 9:15 am

Welcome address and Introduction to workshop

Dr. Zainab Ghazala

9:15 am - 10:00 am

 

ICH GCP R2, draft R3 and Indian GCP

Q&A session

Dr. Anuradha H.V

10:00 am -10:45 am

Responsibilities of Investigator and Clinical Research Coordinator

Q&A session

Dr. Zainab Ghazala

10:45 am – 11:00 am

Tea break

11:00 am - 11:45 pm

National Ethical Guidelines for Biomedical Health Research -2017

Q&A session

Dr. Anuradha H.V

11:45 am -12:30 pm

Good Laboratory Practices: An overview

Dr. Zeenath Begum

12:30 pm – 1:15 pm

Informed consent process, confidentiality, conflict of interest

Q&A session

Dr. Zainab Ghazala

1:15 pm – 2:00 pm

Lunch Break

2:00 pm – 2:45 pm

 Highlights of New Drugs and Clinical Trial Rules, (NDCT) 2019

Q&A session

Dr. Anuradha H.V

2:45 pm – 3:30 pm

Principles Of Research Among Vulnerable Population

Q&A session

Dr. Zainab Ghazala

3:30 pm – 3.45 pm

Tea break

3.45 pm to 4.30 pm

Responsibilities of the Institutional Ethics Committee and Ethical Review Procedures

Q&A session

Dr. Anuradha H.V

4.30 pm - 5:00 pm

Valedictory & Certificate distribution


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