ICH E6 (R3) Draft: A Discussion

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.

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

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#: 0778-0000-23-075-L99-P. Released: 9/23. 

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