Risk-Based Quality Management in Clinical Trials, Implications Implementation Challenges

Risk-Based Quality Management in Clinical Trials

This practical course provides an in-depth understanding of GCP requirements (ICH E6 R3 and ICH E8 R1) regarding Risk Management in clinical trials.

Count Every Second Until the Event

Date: 20, 21 April 2026

0 days 00 hr 00 min 00 sc

Course Overview

This practical course provides an in-depth understanding of GCP requirements (ICH E6 R3 and ICH E8 R1) regarding Risk Management in clinical trials, its practical implications and potential supportive tools, as well as insights into current GCP inspection observations relating to Risk Management. This course will provide sufficient opportunities to discuss best working practices with other participants representing clinical research sponsor teams.

Key Topics

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

Discussing clinical trial risk management according to ICH E6 R3 requirements

Outlining the link between ICH E6 R3 and ICH E8 R1 requirements

Deciding on Critical to Quality Factors for your trials

Setting pre-specified acceptable ranges and quality tolerance limits

Becoming aware of the challenges

Discussing current inspection outcomes regarding Risk Management in clinical trials

Workshops and interactive discussions

Learning Outcomes

Taking away the requirements for Risk Management in clinical trials
Having full awareness of the potential inspection risks
Developing best practices and implementation of Risk Management processes
Improving your standard operating procedures covering risk management

Who Should Attend

Clinical Operations
Clinical Project Management
Clinical Quality Assurance
Clinical Quality Project Management
GCP Compliance
Clinical Process Management

Meet Your Trainer

Jeannette Dixon

Jeannette has held GCP quality-focused positions since 2008 at various pharmaceutical companies, and started her own consultancy business in 2017, including employment as Director R&D QA at A Gene Therapy biotech company. Prior to transitioning to GCP/GCLP work, she held positions in pharmaceutical training management, project management in Phase I-IV projects, worked as CRA and in academic research laboratories. Jeannette led quality teams and has extensive experience in Quality Management System (QMS) development, managing audits, CAPAs, risk management and inspection readiness activities as well as in hosting several regulatory agency inspections.

Her educational background is a BSc in Medical Sciences, a BSc in Pharmacology, and a Master in Quality Management. She enjoys traveling, cycling, swimming, and painting, and hopes to be able to see a few more deserts in the world