{"product_id":"12-hour-drug-safety-and-pharmacovigilance-effective-drug-safety-reporting-and-surveillance-2026-11-19","title":"12-Hour 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\u003ePrior to the start of the course, participants will receive their login credentials and links to access and download the many class resources and class meeting links. Upon course completion, participants will be provided training certificates. In order to receive accreditation CEUs, participants are required to pass a final exam. Upon completion of the exam, CEU certificates will be provided.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul 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\"\u003eCourse Outline\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eModule 1: Overview of Pharmacovigilance\u003c\/li\u003e \u003cli\u003eModule 2: Adverse Event Reporting and Regulatory Reporting Requirements\u003c\/li\u003e \u003cli\u003eModule 3: PV Audits and Inspections\u003c\/li\u003e \u003cli\u003eModule 4: Signal Management\u003c\/li\u003e \u003cli\u003eModule 5: Periodic Reporting and Risk Management\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul 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\u003eNOTE: This course is for individual registrants only and does not allow for group training.\u003c\/p\u003e\u003cp\u003e\u003cb\u003eWhat participants say about Barnett's 10-Week courses ...\u003c\/b\u003e \u003c\/p\u003e\u003cp\u003e\"Great course! Instruction is expertly led and engaging. I will recommend Barnett to any colleague and will seek out topics for my own future training and professional development needs.\"\u003c\/p\u003e\u003cp\u003e\"The course has been so incredibly helpful thus far...I look forward to Thursday evenings!\"\u003c\/p\u003e\u003cp\u003e\"This class exceeded my expectations of an online learning experience. The instructor was knowledgeable, came equipped with great examples to keep the class interesting and is a strong presenter. Thank you!\"\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp\u003eIndu Kayarat\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\"\u003e\u003cspan class=\"purple-link\"\u003e\u003cb\u003e\u003ci\u003eCourse Length and Time\u003c\/i\u003e\u003c\/b\u003e\u003c\/span\u003e\u003c\/p\u003e\u003cp\u003e3 hours\/week for 4 weeks.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e$1,595 by Early Bird Deadline\u003c\/p\u003e\u003cp\u003e$1,795 after Early Bird Deadline\u003c\/p\u003e\u003cp\u003eThis course is for individual registrants only and does not allow for group training.\u003c\/p\u003e\u003cp\u003eAll participants are eligible for \"Certificates of Attendance,\" and accreditation, provided that accreditation requirements are met.\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 12 hours (1.2 CEUs) of continuing education credit for full participation, including the completion of a final exam and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-25-050-L99-P. Released: 6\/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":53375370330477,"sku":"BI17490","price":1795.0,"currency_code":"USD","in_stock":true},{"title":"Academic","offer_id":53375370363245,"sku":"BI17490-ACADEMIC","price":1595.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/12-hour-drug-safety-and-pharmacovigilance-effective-drug-safety-reporting-and-surveillance-2026-11-19","provider":"Barnett International ","version":"1.0","type":"link"}