ICH-GCP E6 R3

This training covers ICH-GCP E6 R3 principles, regulatory requirements, and data integrity to ensure patient safety in clinical research. Participants will learn about the Declaration of Helsinki, roles and responsibilities, and essential records. Ideal for newcomers, professionals needing a refresher, or those starting a career in clinical research.

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Date: 8th October 2025

0 days 00 hr 00 min 00 sc
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Course Overview

This comprehensive ICH-GCP E6 R3 training is designed to equip professionals in clinical research with a thorough understanding of the latest regulatory updates, ethical guidelines, and data integrity requirements. Participants will gain insights into the Declaration of Helsinki, ICH-GCP E6 R3 principles, and the roles and responsibilities of investigators, sponsors, and ethics committees.

Key Topics

We, at Wehive, offer you in-house training programmes conducted by inspiring coaches that are

Regulatory Framework & Ethics

Scope & Principles

Roles & Responsibilities

Data Governance

Essential Documents

Workshops & Practical Application

Learning Outcomes

  • Understand the regulatory requirements to protect patients’ safety and ensure data integrity
  • Describe the Declaration of Helsinki principles
  • Being able to describe the ICH-GCP E6 R3 scope
  • Understand the ICH-GCP E6 R3 principles
  • Explain the roles and responsibilities described in ICH-GCP E6 R3
  • Describe the data governance requirements
  • Knowing what the essential records are

Who Should Attend?

An event precisely for you
  • Any people working in Clinical research that needs to be totally refreshed on ICH-GCP
  • Any new people in Clinical research that needs to be trained on ICH-GCP E6 R3
  • People who wanted to start a career in Clinical Research

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. 

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