ICRI ICH-GCP WORKSHOP
This is to inform we are organizing "ICH-GCP WORKSHOP” from “6th April 2015 to 8th April 2015” at “MUMBAI CAMPUS”
This three day workshop aims to provide an overview of the essential
elements of ICH-GCP. The principles of ICH-GCP will be explained along with
practical examples on ICH-GCP implementation which will help you in
Industry.
Agenda is mentioned below:
Date: 6 April 2015
TIME |
EVENT |
TOPICS COVERED |
10:00-11:00 |
Introduction to GCP |
Origin,
Declaration of Helsinki, International Conference on Harmonisation (ICH),
ICH-GCP Principles |
11:00-12:00 |
Independent Review Board |
Independent
Review Board, Composition, Requirements, Responsibilities |
12:00-12:15 |
Break |
|
12:15-01:00 |
Exercise |
Date: 7 APRIL 2015
TIME |
EVENT |
TOPICS COVERED |
10:00-11:00 |
Investigator Responsibilities |
Qualifications,
Responsibilities, Documentation |
11:00-12:00 |
Informed Consent Process |
Best
Practice, Documentation, |
12:00-12:15 |
Break |
|
12:15-01:00 |
Group Discussion |
Date: 8 APRIL 2015
TIME |
EVENT |
10:00-11:00 |
Sponsor Responsibilities |
11:00-12:00 |
Case Studies |
12:00-12:15 |
Break |
12:15-01:00 |
Assessment |
NOTE : STUDENTS WHO WILL HAVE 100% ATTENDANCE IN THESE THREE DAYS
AND QUALIFY ASSESSMENT WITH MORE THAN 75 % MARKS WILL ONLY BE
AWARDED WITH CERTIFICATES.
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