{"product_id":"ich-e6-r3-and-ich-e8-r1-updates-impact-on-sponsors-2026-10-20","title":"ICH E6 (R3) and ICH E8 (R1) Updates: Impact on Sponsors","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cdiv\u003e\u003cp\u003eThe 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.\u003cbr\u003e\u003c\/p\u003e\u003c\/div\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eIntroduce rationale, revisions, and release to ICH E6(R3)\u003c\/li\u003e \u003cli\u003eReview changes to principles in ICH E6(R3)\u003c\/li\u003e \u003cli\u003eIntroduce rationale, revisions, and release of E8\u003c\/li\u003e \u003cli\u003eReview CTQ factors that should be considered when planning a study\u003c\/li\u003e \u003cli\u003eDemonstrate that ICH E8 provides cross-referencing to other relevant ICH guidelines for planning and executing development program-related studies\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eSenior Leaders, Directors, and Managers \u003c\/li\u003e \u003cli\u003eClinical Research Associates\u003c\/li\u003e \u003cli\u003eClinical Research Coordinators\u003c\/li\u003e \u003cli\u003eStudy Managers\u003c\/li\u003e \u003cli\u003eQuality Personnel\u003c\/li\u003e \u003cli\u003eData Managers\u003c\/li\u003e \u003cli\u003eBusiness Process Owners\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\u003cspan class=\"purple-link\"\u003e\u003ca href=\"https:\/\/stage.barnettinternational.com\/instructor-biographies\" title=\"Click here for complete trainer biographies\"\u003eClick here for complete trainer biographies\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e$735*\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 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#: 0778-0000-25-043-L99-P. Released: 10\/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":53474476032365,"sku":"BI17488","price":735.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/ich-e6-r3-and-ich-e8-r1-updates-impact-on-sponsors-2026-10-20","provider":"Barnett International ","version":"1.0","type":"link"}