ICH GCP E6 R2 and R3 Updates: Implementing Risk Management Approaches for Compliance
The most profound change in the updated ICH GCP E6 R2 is the new sponsor responsibility, Section 5.0, Quality Management. This section provides detail on implementing a system of quality management; critical process and data identification; risk identification; risk evaluation; risk control; risk communication; risk review; and risk reporting. Further, risk assessment and risk mitigation plans are required, regardless of whether Risk-Based Quality Management (RBQM) is being utilized by the sponsor. These requirements also address: Efficient clinical trial protocol design; data collection tools/ procedures; and, collection of information that is essential to decision making. This web seminar takes an in-depth look at the updated guideline with respect to quality management, as well as the methodology of RBQM. How to apply these guidelines in a step-by-step process with strategies for effective implementation will be reviewed and an example provided. Implications of the R3 updates will also be discussed.
- Define the three-way risk evaluation methodology
- Distinguish between the concepts of risk mitigation and risk acceptance
- Describe the concept of “predefined tolerance limits”
- Describe centralized monitoring
- Define a best practice implementation process 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
Nikki Christison, B.S., C.C.R.A., T.I.A.C.R.
Includes up to 20 participants at one site. 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 sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.
Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: email@example.com
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#: 0778-0000-22-023-L04-P. Released: 7/22.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.