ISCR - Good Clinical Practice (GCP) Workshop for Ethics Committee Members

16 Jul 2022-16 Jul 2022,

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Date: 16 -Jul-2022 (Virtual)                                                                            Time: 9 30 AM –  1:00 PM

Attendees: All Ethics Committees Members providing Oversight for the conduct of Clinical Trials

Agenda:

Sr. No.	PROPOSED TOPIC & CONTENT	Time	Facilitator
1	Welcome and Introduction to ISCR Overview of Clinical Research	9:30 – 10:00	Ruteja Joglekar
2	Historical Development of Ethical Guidelines & Introduction to GCP	10:00 – 10:30	Dr Mrunalini Kalikar
3	Ethical issues in Clinical Trials including Informed consent, Misconduct etc.	10:30– 11 :00	Dr Mrunalini Kalikar
	Break	11: 00 to 11:10
4	NDCT rules, 2019 refresher- EC perspective	11: 10 – 11: 20	Lakshmi  Achuta
5	EC Responsibilities; Regulations for EC registration.	11: 20 to 11:50	Dr Ganesh Dakhale
6	Safety Reporting in Clinical Trials	11:50 – 12:15	Lakshmi Achuta
7	Ethical Review of Clinical Trials – Practical overview  of the review process	12:15– 12 :40	Chandana Pal
8	Risk Benefit Assessment (RBA) -  A Practical approach	12 : 40- 1 :15	Dr Ganesh Dakhale
	Q & A- Vote Of Thanks and Conclusion	1 :15 -1:30

 

 

 

 

 

 

 

 

Agenda

Speakers