{"product_id":"investigator-responsibilities-for-safety-reporting-for-investigational-drugs-and-devices-fda-s-final-guidance-2025-2026-12-05","title":"Investigator Responsibilities for Safety Reporting for Investigational Drugs and Devices: FDA's Final Guidance 2025","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e \u003cp\u003eIn response to IRB's concerns regarding the reporting of relevant safety information, the FDA released safety reporting guidance in 2009. Last updated in 2012, the subsequent guidance documents continued to focus on reporting requirements for IND and BA\/BE studies. In December 2025, FDA released its most recent update, along with its companion guidance for Sponsors, includes safety reporting guidance for pharmaceutical\/biologics and medical device studies and provides clarifying definitions and examples to assist Clinical Investigators in meeting their regulatory obligations for safety reporting. This webinar will explore the FDA's current thinking on requirements for reporting safety events as evidenced in the final guidance.\u003c\/p\u003e \u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e \u003cul type=\"disc\"\u003e \u003cli\u003eReview the FDA's definitions of \"reasonable possibility\", \"serious\", and other terms\u003c\/li\u003e \u003cli\u003eEvaluate clarifications for who makes decisions regarding causality and classification\u003c\/li\u003e \u003cli\u003eDiscuss examples of UPIRTSOs and plans for reporting\u003c\/li\u003e \u003cli\u003eAssess expectations for Investigator review of safety reports\u003c\/li\u003e \u003cli\u003eConsider FDA's alternative pathway for reporting responsibilities\u003c\/li\u003e \u003cli\u003eExplore FDA's examples of what is reportable and what is not\u003c\/li\u003e \u003cli\u003eInvestigate the complementary elements of the FDA's Final Guidance for Sponsor Responsibilities for safety reporting\u003c\/li\u003e \u003c\/ul\u003e \u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e \u003cul type=\"disc\"\u003e \u003cli\u003eThis course is intended for Clinical Investigators, and IRB and Sponsor\/CRO representatives who require an understanding safety reporting regulations and requirements.\u003c\/li\u003e \u003c\/ul\u003e \u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e \u003cp\u003eElizabeth Ronk Nelson, M.P.H.\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\"\u003eAccreditation\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 2.0 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.\u003c\/p\u003e\u003cp\u003eACPE#: 0778-0000-26-001-L99-P Released: 5\/26.\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":53375393956205,"sku":"BI17673","price":735.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/investigator-responsibilities-for-safety-reporting-for-investigational-drugs-and-devices-fda-s-final-guidance-2025-2026-12-05","provider":"Barnett International ","version":"1.0","type":"link"}