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TMH, Mumbai
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GCP 2025
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GCP
ScientificProgram
GOOD CLINICAL PRACTICE 2025
(VIRTUAL GCP-2025)
Home
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SCIENTIFIC
Program Schedule
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Program Schedule
BASIC COURSE
Saturday 26
th
JULY 2025
ADVANCE COURSE
Saturday 26
th
JULY 2025
26
st
July, 2025 (SATURDAY) - BASIC COURSE
Download Basic GCP Program
08:30 am - 09:00 am
Topic: NDCT 2019 and Updates
Speaker:
Amita Bhave
09:00 am - 09:45 am
Topic: Monitoring
Speaker:
Renuka Neogi
09:45 am - 10:30 am
Topic: Evolution of Ethics and Basics of GCP
Speaker:
Durga Gadgil
10:30 am - 11:15 am
Topic: Investigator Responsibilities as per E6/R3
Speaker:
Sachin Sadekar
11:15 am - 12:00 pm
Topic: Informed Consent Document and Informed Consent Process
Speaker:
T. Shiv Kumar
12:00 pm - 12:10 pm
Break
12:10 pm - 12:55 pm
Topic: Safety Reporting in Clinical Trials
Speaker:
Sachin Sadekar
12:55 pm - 01:25 pm
Investigational Product Management at Study Site
Speaker:
Prachi Patil
01:25 pm - 02:05 pm
Source Documents & Data
Speaker:
Shirsha Chakraborty
26
th
July, 2025 (SATURDAY) - ADVANCED COURSE
Download Advanced GCP Program
09:00 am - 09:45 am
Topic: ICH GCP E6/R3
Speaker:
Arun Bhatt
09:45 am - 10:15 am
Topic: Academic Studies and ICMR guidelines
Speaker:
Amit Joshi
10:15 am - 11:15 am
Topic: Declaration of Helsinki 2024
Speaker:
Jeroze Engineer
11:15 am - 12:15 pm
Topic: Rare Diseases and Clinical Development
Speaker:
Jeroze Engineer
12:15 pm - 12:20 pm
Break
12:20 pm - 01:05 pm
Topic: AI and Clinical Research
Speaker:
Arun Bhatt
01:05 pm - 01:40 pm
Topic: CoI and Confidentiality
Speaker:
Swapnali Raut
01:40 pm - 02:15 pm
Topic: Studies in Vulnerable populations
Speaker:
Durga Gadgil
02:15 pm - 03:00 pm
Topic: Decentralized CTs
Speaker:
Sanish Davis