Live Virtual Learning
DURATION OF COURSE
2 Modules / 3.5 hours
At the end of each module, there will be a short question paper to evaluate and embed learning
Electronic certificate of attendance will be issued to each delegate
Module 1 (2 hours)
This is a general GCP overview that identifies the brief history of ICH GCP and the development of The Declaration of Helsinki and of ICH GCP E6 (R2). The eight sections of GCP are briefly described with special emphasis on Sections 4, 5 and 8.
- Section 4: Investigator Responsibilities
- Section 5: Sponsor Responsibilities
- Section 8: Essential Documents and the development of the TMF
Module 2 (1.5 hours)
This module contains revised or updated guidance and expectations and looks at the changes wrought by the ICH GCP R2 version. In particular, those relating to risk management.
This module also looks at why the revisions to ICH GCP were necessary
Key topics where the regulators have identified issues
Tutors are comprised of
Fiona Waddell, Director