{"product_id":"drug-safety-and-pharmacovigilance-effective-drug-safety-reporting-and-surveillance-2026-10-15","title":"Drug Safety and Pharmacovigilance: Effective Drug Safety Reporting and Surveillance","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThis course covers the fundamentals of drug safety and pharmacovigilance, including regulatory requirements, adverse event reporting, signaling and risk management. The course addresses the regulatory issues across U.S. and EU agencies that improve safety, but slow down the product approval process. Keeping products on the market without interruption becomes more essential with the reduced pipeline of drugs in development. Successful navigation of drug safety and pharmacovigilance are keys to product longevity, consumer confidence, and regulatory compliance. This course will provide learners with regulatory references, processes, best practices, and analysis and investigation techniques to minimize risk, avoid product recall, and meet U.S. and EU safety reporting standards.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul style=\"list-style-type:disc;\"\u003e \u003cli\u003eDescribe regulatory requirements for product safety \u003c\/li\u003e \u003cli\u003eSignal detection, risk assessment and management functions\u003c\/li\u003e \u003cli\u003eDefine how to collect, assess, report, and analyze adverse events\u003c\/li\u003e \u003cli\u003eDemonstrate the importance of good adverse event data collection in identifying signals\u003c\/li\u003e \u003cli\u003eSignaling analyses based on FDA Good Pharmacovigilance Practices\u003c\/li\u003e \u003cli\u003eIntroduce FDA Good Pharmacovigilance Practices and EMA Good Pharmacovigilance (GVP) Modules and their relevance to Aggregate Reporting, Risk Management, and Signal Detection\u003c\/li\u003e \u003cli\u003eIdentify differences between U.S. and European regulatory requirements\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul style=\"list-style-type:disc;\"\u003e \u003cli\u003eDrug Safety and Pharmacovigilance Professionals\u003c\/li\u003e \u003cli\u003eRegulatory Affairs Professionals\u003c\/li\u003e \u003cli\u003eSenior Level Executives\u003c\/li\u003e \u003cli\u003eClinical Development Staff\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp class=\"bold-italic\"\u003eThe course will be led by one of the following instructors: \u003c\/p\u003e\u003cp\u003eIndu Kayarat\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\"\u003eCourse Outline\u003c\/p\u003e\u003cp class=\"bold-italic\"\u003eDay One\u003c\/p\u003e\u003cul style=\"list-style-type:disc;\"\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eWhat is Pharmacovigilance?:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eDefinition and history; corporate pharmacovigilance; ADR system; critical elements\u003c\/span\u003e\u003cspan class=\"normal-text\"\u003e\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eWhat is an Adverse Event Drug Reaction?:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eAdverse Drug Reaction definition; sources of SADRs; types of ADRs; ADR reports to FDA\/EMEA; serious ADR; unlabeled or unexpected ADR; expectedness \"listed\" vs. \"unlisted\"; severity\/intensity; lack of efficacy; pharmacovigilance\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eGlobal Regulatory References and Expectations:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eGlobal regulations addressing safety (ICH, CIOMS, FDA and EU)\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cb\u003eRegulatory Reporting:\u003c\/b\u003e Expedited reporting timelines; aggregate reports and timelines\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"bold-italic\"\u003eDay Two \u003c\/p\u003e\u003cul style=\"list-style-type:disc;\"\u003e \u003cli\u003e \u003cb\u003ePV Audits and Audit Issues:\u003c\/b\u003e Regulatory inspections; preparation, problems and issues; checklists; ADR; inspection principles; inspection results; potential regulatory actions\u003c\/li\u003e \u003cli\u003e \u003cb\u003eSignaling:\u003c\/b\u003e \u003cspan class=\"normal-text\"\u003eWhat is safety signal; safety signal generation; definition; pharmacovigilance process; risk\/benefit; situations for signal detection; sources of signals; analysis and investigation of a signal; understanding safety signals; suspected signals, risk assessment\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003e\u003cb\u003eCharacteristics of a Good Case Report:\u003c\/b\u003e \u003c\/span\u003eHow to do a narrative evaluation for follow-up; active query; investigator's brochure; safety; interim update for investigators; FDA time\/report obligations; regulatory reporting and notification\u003c\/li\u003e \u003cli\u003e \u003cb style=\"background-color:transparent;color:inherit;text-align:inherit;text-transform:inherit;white-space:inherit;word-spacing:normal;caret-color:auto;font-size:inherit;\"\u003eRisk Management: \u003cspan class=\"normal-text\"\u003e \u003c\/span\u003e\u003c\/b\u003e \u003cspan class=\"normal-text\"\u003eUnderstanding Risk Evaluation and Mitigation Strategy (REMS) and Risk Management Plans (RMP)\u003c\/span\u003e\u003cb style=\"background-color:transparent;color:inherit;text-align:inherit;text-transform:inherit;white-space:inherit;word-spacing:normal;caret-color:auto;font-size:inherit;\"\u003e\u003cspan class=\"normal-text\"\u003e\u003c\/span\u003e\u003c\/b\u003e \u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInteractive Activities\u003c\/p\u003e\u003cul style=\"list-style-type:disc;\"\u003e \u003cli\u003eCase Study Reviews \u003c\/li\u003e \u003cli\u003eExercises in Drug Safety concepts\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cdiv\u003eThis course is for individual registrants only and does not allow for group training.\u003c\/div\u003e\u003cdiv\u003e \u003c\/div\u003e\u003cdiv\u003e\u003cp\u003eSpecial rates are available for multiple attendees from the same organization. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for more information. Or email Customer Service at: customer.service@barnettinternational.com.\u003c\/p\u003e\u003c\/div\u003e\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca href=\"\/pages\/faqs\" title=\"Click here for our seminar cancellation policy\"\u003eClick here for our seminar cancellation policy\u003c\/a\u003e\u003c\/span\u003e\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 15 hours (1.5 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#: 0778-0000-24-056-L99-P. Released: 10\/24. \u003c\/p\u003e\u003cp style=\"text-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":53474464760173,"sku":"SSVJ1026","price":1895.0,"currency_code":"USD","in_stock":false}],"url":"https:\/\/www.barnettinternational.com\/products\/drug-safety-and-pharmacovigilance-effective-drug-safety-reporting-and-surveillance-2026-10-15","provider":"Barnett International ","version":"1.0","type":"link"}