Course Description

While ICH E6 (R2) incorporated evolutions in technology and risk management processes to better reflect changes in the scale, complexity, and cost of clinical trials, the draft ICH E6 (R3) focuses on clinical trials’ critical-to-quality factors that support the fundamental goal of Good Clinical Practice (GCP): Credible data from protected participants. Reimagined to align with, and support, key concepts of ICH E8 (R1), the draft of ICH E6 (R3) focuses on fostering a proactive risk-based quality culture and design for interventional clinical studies of regulated products. Updates include information on Quality by Design, clinical trial registration, and noncompliance, among others. This web seminar reviews the major revisions and new elements of the guideline aimed at facilitating innovations in clinical trial design, technology, and operational approaches.

Video Preview

Learning Objectives

• Review the revised structure and its purpose
• Evaluate changes in the principles of GCP
• Examine updates to the glossary
• Consider the impact of modifications in core requirements, roles, and responsibilities
• Assess clarifications for investigator’s brochures and protocols
• Explore new guidance for data governance and essential records
• Investigate the complementary elements of ICH E8 (R1) General Considerations for Clinical Studies for identification and management of risks to study quality

Who Should Attend

• Clinical, Regulatory, and Quality Personnel who require an understanding of the GCP regulations and requirements
• Other Personnel who must be familiar with the essentials of the clinical process and requirements

Instructor

Elizabeth Ronk Nelson, M.P.H.

Click here for complete trainer biographies

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