{"product_id":"ich-e8-r1-designing-quality-into-clinical-studies-2026-12-08","title":"ICH E8 (R1): Designing Quality into Clinical Studies","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eICH E8(R1) is intended to identify and modernize the present conduct of clinical research, including clinical trial design, planning, management, and conduct. In clinical research, quality assurance activities of retrospective document checking, monitoring, auditing, or inspection are essential, and there has been an overreliance on these tasks versus relying on designing quality into clinical studies during development and throughout clinical research. This web seminar covers the importance of designing quality into clinical trials with a focus on Quality by Design (QbD) of clinical studies, critical factors to quality, essential identification of quality factors, establishing a culture that supports critical thinking and open dialogue regarding proactive quality versus reliance on tools\/checklists, and stakeholder engagement.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eDescribe ICH E8(R1): Designing Quality into Clinical Studies\u003c\/li\u003e \u003cli\u003eDefine critical factors to quality in ensuring human subject protection and generation of reliable and meaningful results\u003c\/li\u003e \u003cli\u003eIdentify an appropriate framework for the identification and review of essential elements of quality in clinical studies\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eManagers\/Directors: Clinical Operations, Clinical Research, Data Management, Quality Management, Compliance, Process Improvement, Risk Management, Quality Risk Management\u003c\/li\u003e \u003cli\u003eStudy Managers\/Project Managers\u003c\/li\u003e \u003cli\u003eClinical Research Associates\/Monitors\u003c\/li\u003e \u003cli\u003eRegulatory Affairs Professionals \u003c\/li\u003e \u003cli\u003eBiostatisticians, Data Managers \u003c\/li\u003e \u003cli\u003eClinical Research Nurses, Clinical Research Coordinators, Clinical Investigators\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp\u003eAndy Lawton\u003c\/p\u003e\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca href=\"https:\/\/www.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 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#: 0778-0000-23-059-L99-P. Released: 7\/23. \u003cspan class=\"bold\"\u003e\u003c\/span\u003e \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":53474476523885,"sku":"BI17578","price":735.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/ich-e8-r1-designing-quality-into-clinical-studies-2026-12-08","provider":"Barnett International ","version":"1.0","type":"link"}