{"product_id":"risk-based-quality-and-compliance-management-in-combination-product-trials-2026-08-08","title":"Risk-Based Quality and Compliance Management in Combination Product Trials","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eA risk-based approach to clinical trials requires not only a strategy, but tools to define key indicators to measure specific risks. As referenced in the most recent U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidance documents, Key Risk Indicators (KRIs) and Critical to Quality (CTQ) metrics should focus on \"what really matters,\" and safety of research subjects and data integrity should be emphasized. Combination products can increase risks while being tested in clinical trials, therefore, these metrics should be linked to particular processes within a development program for combination products. \u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eReview the different types of combination products \u003c\/li\u003e \u003cli\u003eReview current regulatory updates and guidelines for combination products\u003c\/li\u003e \u003cli\u003eDiscuss streamlined approach for combination products\u003c\/li\u003e \u003cli\u003eDescribe principles of Quality by Design (QbD) and new regulatory requirements for risk-based monitoring and how it applies to trials with combination products\u003c\/li\u003e \u003cli\u003eDevelop relevant metrics as quality and performance indicators for Risk-Based Quality Management (RBQM) systems for combination products\u003c\/li\u003e \u003cli\u003ePerform a cause-effect analysis for identified risks and develop mitigation strategies\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eClinical Quality Assurance Auditors\u003c\/li\u003e \u003cli\u003eClinical Quality and Compliance Professionals \u003c\/li\u003e \u003cli\u003eClinical Research Associates\u003c\/li\u003e \u003cli\u003eProject Managers\u003c\/li\u003e \u003cli\u003eMedical Monitors\u003c\/li\u003e \u003cli\u003eRegulatory Affairs Professionals\u003c\/li\u003e \u003cli\u003eClinical Research Investigators and Coordinators \u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp\u003eMarina Malikova, Ph.D., MSci, M.A., C.C.R.A., RAC\u003c\/p\u003e\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca href=\"\/pages\/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#: 0778-0000-25-047-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":53375390548333,"sku":"BI17357","price":735.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/risk-based-quality-and-compliance-management-in-combination-product-trials-2026-08-08","provider":"Barnett International ","version":"1.0","type":"link"}