ICH-GCP E6 R3 vs R2

This module explores the critical updates in ICH-GCP E6 (R3) compared to R2, emphasizing changes in ethical oversight, investigator and sponsor responsibilities, and data integrity. Attendees will learn how these updates enhance patient safety, trial efficiency, and compliance with evolving regulatory standards.

Count Every Second Until the Event

Date: 18th June 2025

0 days 00 hr 00 min 00 sc
Request agenda

Course Overview

This training provides a clear understanding of the key updates in ICH-GCP E6 (R3) and how they differ from R2. Participants will explore revised principles, expanded responsibilities, and new data governance requirements. The course includes interactive workshops, discussions, and quizzes for practical implementation. Ideal for clinical professionals, it ensures compliance with the latest Good Clinical Practice standards.

Key Topics

We, at Wehive, offer you in-house training programmes conducted by inspiring coaches that are
Overview of ICH-GCP Revisions
New Principles in ICH-GCP R3
Roles and Responsibilities Updates
Data Governance and Compliance
Essential Documents and Appendices
Implementation and Practical Application

Learning Outcomes

  • Understand the general consideration for the revision of ICH-GCP R2
  • Being able to describe the main changes between ICH-GCP R2 and R3
  • Knowing where to start for ICH-GCP R3 implementation
  • Describe the data governance requirements

Who Should Attend

Any Clinical operation functions trained on ICH-GCP R2 that needs to be informed on the R3 requirements

Meet Your Trainer

Nelle Stocquart

With a master’s in chemistry Nelle Stocquart works since 2003 in the Clinical Research world. She was first an IVRS project manager for a Belgian CRO but then she wished gaining more experience on the field and became CRA for a top 5 international CRO where she got involved in many international phases II & III from early study stage till closure.

She then evolved as project manager in pharmaceutical companies and CRO where she managed local and international studies from phase I to phase IV. She is now working for the Belgian government which is funding academic studies. Nelle has a lot of experience in project management, team management and people coaching. Training, Coaching, Education and Continuous Professional Development have always been the common pillars in her educational path and professional career. She speaks fluently 3 languages (Dutch, French and English).

Her real passions are “technical skills”-trainings:

-Project Management 
-Risk Management 
-Risk Based Monitoring 
-CRO Selection and Management 
-Time Management 
-Clinical trial budget management 
-Advanced Project Management 

She provides standardized training, but also tailor-made sessions adapted to the specific needs of the client and the company. 

Request to Assign a Team Member!

Request Agenda Form | R3