ICH GCP E6 R2 and R3 Updates: Changes Impacting Sponsors/CROs

Course Description

ICH GCP E6 R2 was the first revision in 20 years and included changes that are prescriptive, detailed and more consistent with the rapid, ongoing changes in the complexity and rising cost of clinical trials. Understanding these changes and how they impact your organization is the first critical step towards implementation. This web seminar will describe the addendums in a step-by-step process and provide a parallel discussion of how the revised guideline can improve efficient approaches to trial management. Discussion topics include: The effects on sponsors/CROs; clinical trial design; trial conduct and monitoring; and oversight/documentation and reporting. Practical information on how to incorporate the revisions to better manage human subject projection, understand the new definitions for monitoring plan, certified copy, and computerized systems, explore changed responsibilities to ensure data quality and integrity will also be provided. Implications of the R3 updates will also be discussed.

Learning Objectives

• Identify three changes that impact sponsors/CROs and individual roles
• Explain the impact of the revisions on clinical trial conduct and organizational practices
• Discuss opportunities for implementing the revised guideline

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)

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#: 0778-0000-22-020-L04-P. Released: 7/22. 

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