Live Virtual Learning

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

Keeping abreast of changes in regulations and expectations is a regulatory requirement and with this course we provide an overview of the principles of GCP as well as updating those with what is happening in the GCP world and the implications and impact of ICH GCP R2 and GDPR on sponsor and investigator responsibilities.

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

Individuals with a working knowledge of GCP including investigators and other site staff, monitors, CROs, Pharma personnel, QA, and sponsor study personnel who want to maintain or update their existing knowledge base.

Course Tutors

Tutors are comprised of
Fiona Waddell, Director

Course Dates

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