{"title":"ICH GCP E6(R3) Updates: Overview of Changes Impacting Sponsors, CROs, and Clinical Investigators\/Sites","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThe release of ICH GCP E6(R3) marks a significant update to the previous\nversions of the guidelines, reflecting a more flexible, risk-based approach to\nclinical trial management. This revision enhances the framework for clinical\ntrial design, conduct, oversight, and reporting, with an emphasis on improving\ntrial efficiency, data integrity, and the protection of human subjects. The R3\nupdate also refines roles and responsibilities for sponsors, CROs, and clinical\ninvestigators\/sites, aligning them with current best practices and regulatory\nexpectations. This web seminar will provide an overview of the key updates\nin ICH GCP E6(R3), including new definitions, sponsor\/CRO and investigator\nresponsibilities, and essential documents. We will also explore how these\nupdates influence clinical trial processes and provide practical guidance on\nhow to implement these changes within your organization.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e\n\u003cli\u003eExplain the rationale behind the ICH GCP E6 R2 and R3 updates, and their intended impact on clinical trial management\u003c\/li\u003e\n\u003cli\u003eDescribe the key terms and definitions that were introduced or updated in the ICH GCP E6(R3)\u003c\/li\u003e\n\u003cli\u003eIdentify the specific changes in the ICH GCP E6(R3) update and proposed updates impacting sponsors, CROs, and clinical investigators\/sites\u003c\/li\u003e\n\u003cli\u003eRecognize the significance of these changes for sponsor\/CRO and investigator\/site responsibilities, and their potential impact on clinical trial conduct\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e\n\u003cli\u003eManagers\/Directors: Clinical Operations, Clinical Research, Quality Management, Compliance\u003c\/li\u003e\n\u003cli\u003eStudy Managers, Project Managers\u003c\/li\u003e\n\u003cli\u003eClinical Research Associates\/Monitors\u003c\/li\u003e\n\u003cli\u003eQuality Assurance Personnel\u003c\/li\u003e\n\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\n\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\n            biographies\u003c\/a\u003e\u003c\/span\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\n    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#: 0778-0000-25-034-L04-P. Released: 4\/25. \u003c\/p\u003e\u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003eHold\n this course at your company! For more information, contact Naila Ganatra at +1\n        215.413.2471. \u003c\/span\u003e\u003c\/p\u003e","products":[],"url":"https:\/\/www.barnettinternational.com\/collections\/ich-gcp-e6r3-updates-overview-of-changes-impacting-sponsors-cros-and-clinical-investigators-sites.oembed","provider":"Barnett International ","version":"1.0","type":"link"}