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Management Forum

Practical Risk Management in Clinical Research and Trials Training Course

Aligned with ICH GCP E6 (R3) and ICH E8 (R1)

This essential course will explain the importance of using risk management techniques in clinical trials to comply with the latest focus on inspection in this area.

★★★★★ "Very good"

24 April 2026
+ 6 October 2026 »
from £649

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Course overview

Risk management is now central to regulatory expectations in clinical research. Under ICH GCP E6 (R3) and ICH E8 (R1), sponsors and investigators must implement proportionate, risk-based approaches that protect participant safety, ensure data integrity, and demonstrate effective oversight throughout the clinical trial lifecycle.

Regulators increasingly expect organisations to show how risk is identified, assessed, managed and monitored in practice - not simply documented in theory.

This course provides a practical, inspection-focused guide to implementing risk management within clinical trials and clinical quality systems. It bridges regulatory expectations with real-world tools and processes that can be applied immediately in sponsor, CRO and study site environments.

Browse our extensive selection of Life Sciences training courses for industry-leading insights into a range of topics. These include Medical Devices, IVDs, Biotech and Biopharma, Animal Health and Pharmaceutical training courses.

Benefits of attending

Understand regulatory expectations for risk management under ICH GCP E6 (R3) and ICH E8 (R1)
Learn how to identify and prioritise Critical-to-Quality (CtQ) factors
Apply practical tools for risk identification, assessment and control
Integrate risk management into your Quality Management System (QMS)
Link risk findings to CAPA, oversight and continuous improvement
Be better prepared to explain and defend your risk processes during inspections

Who should attend

This course is designed for professionals involved in clinical research and trial oversight, including:

Clinical Operations and Study Management
Quality Assurance and Compliance
Regulatory Affairs
Risk and Quality Management Professionals
Clinical Project Managers
CRO and Vendor Oversight Personnel
Clinical Trial Managers and CRAs

It is suitable for those implementing risk-based approaches, updating systems in line with ICH GCP E6 (R3), or preparing for regulatory inspection.

Enrol/reserve

This course will cover:

Introduction to risk management in clinical trials

Core risk management principles and terminology
Evolution of risk-based approaches in clinical research
Why risk management is critical to trial quality and compliance

Regulatory framework and critical-to-quality thinking

Risk expectations under ICH GCP E6 (R3)
Proportionate, risk-based approaches in practice
Critical-to-Quality (CtQ) factors and Quality Tolerance Limits (QTLs)

Risk-based quality management systems

Integrating risk into clinical processes and governance
Documentation and evidence inspectors expect
Applying risk management within a clinical QMS

Risk tools used in clinical trials

Risk logs, risk matrices and prioritisation techniques
Failure Mode and Effect Analysis (FMEA) and structured methodologies
Risk tracking, scoring systems and escalation mechanisms

Managing and monitoring risk in practice

Linking risk to monitoring strategies and oversight
Root Cause Analysis and CAPA
Sponsor and investigator responsibilities under ICH GCP E6 (R3)

Risk-based oversight and continuous improvement

Risk-based auditing and inspection readiness
Learning from inspection findings
Continuous improvement and governance

Enrol/reserve

Laura Brown
Independent Pharmaceutical Consultant

Dr Laura Brown is an independent pharmaceutical QA, management and training consultant and Senior Lecturer for the MSc in Clinical Research, School of Pharmacy, University of Cardiff. Laura has more than 20 years’ experience of quality assurance and managing international clinical trials including risk identification and management. She has worked for several leading companies including GSK, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International and is an international expert on GCP and clinical trial requirements. Laura was chair of the Institute of Clinical Research GCP Forum for six years and writes regularly on clinical research regulatory requirements.

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

30% off the 2nd delegate*
40% off the 3rd delegate*
50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

24 April 2026

Live online

09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 16872

GBP 649 749
EUR 909 1,049
USD 1,043 1,199

Until 20 Mar

1 day live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

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Not ready to book yet?

for 7 days, no obligation

6 October 2026

Live online

09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 16873

GBP 649 749
EUR 909 1,049
USD 1,043 1,199

Until 01 Sep

1 day live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.