{"product_id":"risk-based-monitoring-and-quality-management-of-clinical-trials-recent-guidance-updates-from-the-fda-and-ema-2026-09-14","title":"Risk-Based Monitoring and Quality Management of Clinical Trials: Recent Guidance Updates from the FDA and EMA","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThe FDA and EMA describe their expectations for risk-based approaches to quality management and monitoring in the 'FDA Guidance Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring' and the 'EMA Reflection Paper on risk-based quality management in clinical trials,' both of which are reviewed in this web seminar, which also includes industry think tank contributions. \u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eDiscuss the FDA Guidance and EMA Reflection Paper for clinical trial risk management and monitoring\u003c\/li\u003e \u003cli\u003eEvaluate industry think tank trends (TransCelerate, CTTI)\u003c\/li\u003e \u003cli\u003eReview best practices for risk management for trial oversight and monitoring\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eClinical Investigators and Staff\u003c\/li\u003e \u003cli\u003eClinical Research Associates\u003c\/li\u003e \u003cli\u003eStudy and Clinical Research Associate Managers\u003c\/li\u003e \u003cli\u003eSponsors\/CROs Clinical Operations\u003c\/li\u003e \u003cli\u003eClinical Quality Compliance and Quality Assurance Professionals\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp\u003eNikki Christison, B.S., C.C.R.A., T.I.A.C.R.\u003c\/p\u003e\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca title=\"Click here for complete trainer biographies\" href=\"https:\/\/stage.barnettinternational.com\/instructor-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#: 0778-0000-25-047-L99-P. Released: 8\/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":53375372788077,"sku":"BI17425","price":735.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/risk-based-monitoring-and-quality-management-of-clinical-trials-recent-guidance-updates-from-the-fda-and-ema-2026-09-14","provider":"Barnett International ","version":"1.0","type":"link"}