Course Description

In January 2017, the ICH GCP renovation was initiated, ushering in a new era of regulatory guidelines. The finalization of ICH E8 R1 in 2021 has brought forth a clear roadmap for integrating Quality by Design principles into the design and development of clinical trials. Simultaneously, the draft version of ICH GCP (ICH E6 R3) includes a complete rewrite of existing guidelines, triggering a paradigm shift in how companies approach these changes. While the majority of these changes are anticipated to be embraced by the industry as a means to modernize the regulatory landscape, some formidable challenges will need to be addressed. In this web seminar, we will delve into the subject matter in alignment with the intentions of the International Council for Harmonisation (ICH). We will explore how ICH E6 and E8 complement each other and discuss their implications for the industry’s evolving regulatory environment.

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Learning Objectives

• Describe the regulatory background that has led to the changes
• Explain the changes within ICH E8 R1
• Explain the changes within ICH E6 R3
• Describe the concept of Quality by Design and its application to clinical development
• Understand the role of risk management and measured quality in Quality by Design

Who Should Attend

• Clinical Research Associates/Monitors
• Clinical Trial Leads
• Data Managers/Data Scientists
• Statisticians
• Regulatory Affairs Professionals
• Pharmacovigilance Professionals
• Executive Management

Instructor

Andy Lawton

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