Course Description

The ICH announced an update to GCP guidelines following the release of ICH E6 R2. After eight years, ICH E6 R3 has now been launched, reflecting the modernization needed to align with the evolving clinical development landscape. Along with ICH E8 R1, this update sets the stage for addressing future challenges. The revised guidelines bring both significant conceptual shifts and smaller updates aimed at streamlining the clinical trial process. Many of these updates will be well received across the industry, though some new challenges will need to be navigated. The changes in ICH E8(R1) and their direct impact on ICH E6(R3) will also be examined.

Learning Objectives

• Learn about the regulatory context behind the changes
• Understand the key goals of ICH E6 R3
• Compare ICH E6 R3 with ICH E6 R2 and identify the major differences
• Gain an introduction to Quality by Design and its role in clinical development
• Understand the impact of risk management and quality measures in Quality by Design

Who Should Attend

• Clinical Operations, Onsite Operations, Data Management, and Statistics Managers
• Regulatory Professionals
• Pharmacovigilance Teams

Instructor

Andy Lawton

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Registration Fees

$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 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#: 0778-0000-25-037-L99-P. Released: 3/25. 

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