Course Description

The ICH GCP E6 R3 updates introduce a refined, standardized approach to risk management that builds on previous revisions. A key shift in the updated guidelines is the emphasis on a comprehensive, risk-based approach to quality management, with a clear focus on critical process and data identification, risk evaluation, and mitigation strategies. While Risk-Based Quality Management (RBQM) is now standard practice, the R3 revision also ensures that risk assessment and mitigation plans are required across all clinical trials, regardless of RBQM adoption. This web seminar will explore these updated requirements, focusing on risk management principles, including risk identification, evaluation, control, and reporting. Participants will learn how to apply these principles in clinical trial settings, particularly in protocol design, data collection procedures, and decision-making processes. Practical strategies for implementing the updated guidelines, along with step-by-step methodologies for risk management, will be provided. Additionally, we will discuss the implications of the R3 updates and how they redefine compliance and quality management practices.

Learning Objectives

• Define the three-way risk evaluation methodology introduced in the ICH GCP E6 R3 update
• Distinguish between risk mitigation and risk acceptance, and understand their application in clinical trials
• Describe the concept of "predefined tolerance limits" as part of risk-based management
• Explain the role of centralized monitoring in risk management and quality assurance
• Develop a best practice implementation process for risk management based on practical experience

Who Should Attend

• Managers/Directors: Clinical Operations, Clinical Research, Data Management, Quality Management, Compliance, Process Improvement, Risk Management, Quality Risk Management
• Study Managers/Project Managers, Clinical Research Associates/Monitors (Centralized, On-site)
• Business Process Owners

Instructor

Nikki Christison, B.S., C.C.R.A., T.I.A.C.R.

$835*

*Includes up to 20 participants per login at a single location. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional logins for other locations, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556, or email customer.service@barnettinternational.com for pricing.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 2.5 hours (0.25 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-25-033-L99-P. Released: 4/25. 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.