ICH E6 (R3) and ICH E8 (R1) Updates: Impact on Sponsors
The principles of GCP are designed to be flexible and applicable to a broad range of clinical trials. The updated E6 guideline, along with ICH E8, encourages thoughtful consideration and planning to address specific and potentially unique aspects of an individual clinical trial. This includes evaluation of trial characteristics, such as the design elements, the investigational product being evaluated, the medical condition being addressed, characteristics of the participants, the setting in which the clinical trial is being conducted, and the type of data being collected. Careful consideration of factors relevant to ensuring trial quality, including critical-to-quality (CTQ) factors, are needed for each clinical trial. This web seminar will provide a high-level overview of the drivers and changes planned for implementation.
- Introduce rationale, revisions, and release to ICH E6 (R3)
- Review changes to principles in ICH E6 (R3)
- Introduce rationale, revisions, and release of E8
- Review CTQ factors that should be considered when planning a study
- Demonstrate that ICH E8 provides cross-referencing to other relevant ICH guidelines for planning and executing development program-related studies
Who Should Attend
- Senior Leaders, Directors, and Managers
- Clinical Research Associates
- Clinical Research Coordinators
- Study Managers
- Quality Personnel
- Data Managers
- Business Process Owners
Nikki Christison, B.S., C.C.R.A., T.I.A.C.R.
Click here for complete trainer biographies
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: email@example.com
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 1.5 hours (0.15 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#: 0778-0000-22-034-L04-P. Released: 8/22.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.