{"product_id":"gcp-renovation-ich-e8-r1-and-ich-e6-r3-2026-11-13","title":"GCP Renovation (ICH E8(R1) and ICH E6 (R3))","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eIn January 2017, the ICH GCP renovation was initiated, ushering in a new era of regulatory guidelines. The finalization of ICH E8(R1) in 2021 has brought forth a clear roadmap for integrating Quality by Design principles into the design and development of clinical trials. Simultaneously, ICH GCP (ICH E6(R3)) includes a complete rewrite of existing the guideline, triggering a paradigm shift in how companies approach these changes. While the majority of these changes are anticipated to be embraced by the industry as a means to modernize the regulatory landscape, some formidable challenges will need to be addressed. In this web seminar, we will delve into the subject matter in alignment with the intentions of the International Council for Harmonisation (ICH). We will explore how ICH E6 and E8 complement each other and discuss their implications for the industry's evolving regulatory environment.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eDescribe the regulatory background that has led to the changes\u003c\/li\u003e \u003cli\u003eExplain the changes within ICH E8(R1)\u003c\/li\u003e \u003cli\u003eExplain the changes within ICH E6(R3)\u003c\/li\u003e \u003cli\u003eDescribe the concept of Quality by Design and its application to clinical development\u003c\/li\u003e \u003cli\u003eUnderstand the role of risk management and measured quality in Quality by Design\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eClinical Research Associates\/Monitors\u003c\/li\u003e \u003cli\u003eClinical Trial Leads\u003c\/li\u003e \u003cli\u003eData Managers\/Data Scientists\u003c\/li\u003e \u003cli\u003eStatisticians\u003c\/li\u003e \u003cli\u003eRegulatory Affairs Professionals\u003c\/li\u003e \u003cli\u003ePharmacovigilance Professionals\u003c\/li\u003e \u003cli\u003eExecutive Management\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp\u003eAndy Lawton\u003c\/p\u003e\u003cp\u003e\u003ca href=\"https:\/\/www.barnettinternational.com\/instructor-biographies\" title=\"Click here for complete trainer biographies\" style=\"font-family:inherit;font-size:inherit;text-align:inherit;text-transform:inherit;white-space:inherit;word-spacing:normal;\"\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 2.5 hours (0.25 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#: 0778-0000-25-036-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":53474475082093,"sku":"BI17530","price":835.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/gcp-renovation-ich-e8-r1-and-ich-e6-r3-2026-11-13","provider":"Barnett International ","version":"1.0","type":"link"}