{"product_id":"ich-gcp-e6-r3-updates-sponsor-quality-management-risk-based-risk-management-requirements-and-approaches-for-compliance-2026-10-30","title":"ICH GCP E6 (R3) Updates: Sponsor Quality Management - Risk-Based\/Risk Management Requirements and Approaches for Compliance","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThe ICH GCP E6(R3) update refines the focus on quality management in clinical trials, shifting towards a more structured and risk-based approach to trial oversight. Building on the previous guidance from E6 R2, the R3 revision emphasizes the importance of a Clinical Quality Management System (cQMS) to ensure quality throughout the entire clinical trial lifecycle-from design through to archiving. This web seminar will explore the sponsor's responsibilities in implementing and maintaining a risk-based quality management system, highlighting new requirements introduced in E6(R3). Industry benchmarks, standards, and best practices for establishing cQMS, as well as practical approaches to achieve compliance will also be covered. Additionally, the web seminar will address the implications of the R3 updates, including how these changes influence risk management and trial quality oversight.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eDescribe two new requirements for sponsor quality management (QM) in clinical trials as outlined in ICH GCP E6(R3)\u003c\/li\u003e \u003cli\u003eIdentify two risk-based approaches to achieving compliance with QM throughout the clinical trial lifecycle\u003c\/li\u003e \u003cli\u003eDetermine next steps for evaluating and implementing the new quality management requirements in clinical trials\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eTrial Managers\u003c\/li\u003e \u003cli\u003eProject Managers\/Directors\u003c\/li\u003e \u003cli\u003eClinical Quality Assurance\/Compliance Personnel\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp class=\"bold-italic\"\u003e\u003cb\u003e\u003ci\u003eThe course will be led by one of the following instructors:\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\u003cp\u003eNikki Christison, B.S., C.C.R.A.,T.I.A.C.R.\u003c\/p\u003e\u003cp\u003eSusan M. Leister, M.B.A., Ph.D., CQA, CSSBB\u003c\/p\u003e\u003cp\u003eShelia Russell McCullers, M.S., D.M.\u003c\/p\u003e\u003cp\u003e\u003ca href=\"https:\/\/stage.barnettinternational.com\/instructor-biographies\" title=\"Click here for complete trainer biographies\" style=\"font-family:inherit;font-size:inherit;text-align:inherit;text-transform:inherit;word-spacing:normal;white-space:inherit;\"\u003eClick here for complete trainer biographies\u003c\/a\u003e\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e$835*\u003c\/p\u003e\u003cp\u003e*Includes up to 20 participants per login at a single location. 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 logins for other locations, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556, or email customer.service@barnettinternational.com for pricing.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eAccreditation Information\u003c\/p\u003e\u003cp\u003eBarnett 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#: 0778-0000-25-035-L99-P. Released: 2\/25. \u003c\/p\u003e\u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003eHold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471. \u003c\/span\u003e\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53375369838957,"sku":"BI17502","price":835.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/ich-gcp-e6-r3-updates-sponsor-quality-management-risk-based-risk-management-requirements-and-approaches-for-compliance-2026-10-30","provider":"Barnett International ","version":"1.0","type":"link"}