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.

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