ICH GCP E6 R2 and R3 Updates: Changes Impacting Clinical Investigators, Sites, and IND Holders (Sponsors-Investigators and Institutions)

Course Description

The updated ICH GCP E6 R2 is more descriptive than the previous version and describes 26 items of change. These changes consist of new items in definitions; new sections on investigator responsibilities, including oversight; a substantial new sponsor section on quality management, including risk assessment; monitoring plans defined and implemented; introducing Risk-Based Quality Management; serious breaches, and, a new section on computer validation and electronic records, to name a few. This web seminar explores the changes in detail to promote a better understanding of how they impact clinical trials. Practical information and a systematic approach in assessing organizational SOPs, processes and practices as well as designing modifications to assist with implementation will also be provided. Implications of the R3 updates will also be discussed.

Learning Objectives

• Identify the changes impacting investigator responsibilities and roles
• Explain the impact of the revisions to sites and Sponsors-Investigators
• Evaluate solutions for applicability/modification of organizational SOPs, processes, procedures and staff training
• Apply lessons learned for effective implementation of the ICH GCP E6 R2 guideline
• Explore proposed updates included in the upcoming R3 addendum 

Who Should Attend

• Quality Assurance/Compliance Personnel
• Principal Investigators/Sub-Investigators
• Research Site Staff (Managers, CRCs, Data Managers/Data Entry)
• Managers/Directors: Clinical Operations, Clinical Research, Data Management, Quality Management, Compliance, Process Improvement, Risk Management, Quality Risk Management
• Study Managers/Project Managers, CRAs/Monitors (Centralized, On-site)

Instructor

Nikki Christison, B.S., C.C.R.A., T.I.A.C.R. 

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#: 0778-0000-22-021-L04-P. Released: 7/22. 

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