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 GOOD CLINICAL PRACTICE COURSE 2024

(VIRTUAL GCP-2024)

GCP 2024 PROGRAM OVERVIEW

Saturday 11th May, 2024
GOOD CLINICAL PRACTICE- ADVANCED COURSE

     

BASIC COURSE: Saturday 11th May, 2024

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TIME 

 TOPIC

FACULTY

09.00 am - 9.45 am

 Indian Regulation

Amita Bhave

09.45 am - 10.30 am

 Evolution of Ethics and Basics of GCP

Durga Gadgil

10.30 am - 11.15 am

 Investigator Responsibilities

Anand Pendse
11.15 am - 12 noon Informed Consent Document and Informed Consent Process

Saket Ghaisas
12.00 pm - 12.45 pm Break

Break
12.45 pm - 01.30 pm Safety Reporting in Clinical Trials Harish Naik
01.30 pm - 02.15 pm Investigational Product Management at Study Site  Prachi Patil
02.15 pm - 03.00 pm Source Documents & Data Neha/Shirsha
03.00 pm - 03.30 pm Monitoring Durga Gadgil

      

ADVANCED COURSE: Saturday 11th May, 2024

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TIME 

 TOPIC

FACULTY

09.00 am - 09.45 am

 ICH GCP E6/R3-an update

 Seema Pai 

09.45 am - 10.45 am

 E-Consent

Kishore Kumar

10.45 am - 11.30 am

Investigator  Responsibilitiesin 

Academic Studies

Shiv Kumar.T.

11.30 am - 12.15 pm

 Decentralized CTS

Sanish Davis
12.15 pm - 12.45 pm Break Break
12.45 pm - 01.45 pm AI and Clinical Research Arun Bhatt
01.45 pm - 02.30 pm

Protocol deviations and 

their impact on

Clinical trials

 Durga Gadgil
02.30 pm - 03.15 pm RWE studies Deepa Chodankar

     

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