ICH GCP E6 R2 and R3 Updates: Sponsor Quality Management – Risk-Based/Risk Management Requirements and Approaches for Compliance

Course Description

ICH GCP E6 R2 provided significant detail on implementing a system of quality management with a focus on a risk-based/risk management approach for the trial, also referred to as Risk-Based Quality Management. This web seminar reviews this sponsor requirement and describes the clinical quality management system (cQMS) that should be used to oversee quality during the design, conduct, recording, evaluation, reporting and archiving phases – notably the lifecycle of the clinical trial. Additionally, cQMS industry benchmarks, standards and practices will also be discussed. Implications of the R3 updates will also be discussed.

Learning Objectives

• Describe two new requirements for the sponsor’s quality management (QM) of clinical trials
• Identify two approaches to achieve compliance with QM for the clinical trial lifecycle
• Determine next steps for evaluation and implementation of the new requirements

Who Should Attend

• Trial Managers
• Project Managers/Directors
• Clinical Quality Assurance/Compliance Personnel

Instructor

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

Click here for complete trainer biographies

Registration Fees

$835

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: customer.service@barnettinternational.com 

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 2 hours (0.2 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#: 0778-0000-22-025-L04-P. Released: 7/22. 

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