{"title":"Adverse Events: Managing and Reporting for Pharmaceuticals","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\n\u003cp\u003eThis\ncourse provides an excellent introduction for newcomers to the field of drug\nand biologic product AE reporting, a comprehensive overview of current\napproaches and regulations for professionals in the field, and challenging\nquestions and ideas for the experienced clinical research professional. This\ncourse contains medical device content related only to use in combination\nproducts.\u003c\/p\u003e\n\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\n\u003cul type=\"disc\"\u003e\n\u003cli\u003eExplain the purpose and capability of AE\n     reporting \u003c\/li\u003e\n\u003cli\u003eReview and apply the concepts of\n     seriousness, expectedness, and causality\u003c\/li\u003e\n\u003cli\u003eReview how to describe,\n     characterize, and document adverse events\u003c\/li\u003e\n\u003cli\u003eDiscuss safety issues and reporting\n     obligations associated with clinical trials and marketed products,\n     including combination products\u003c\/li\u003e\n\u003cli\u003eIdentify key concepts related to\n     electronic records\u003c\/li\u003e\n\u003cli\u003eDiscuss the use of various coding\n     systems\u003c\/li\u003e\n\u003cli\u003eDescribe the evolving role of the\n     FDA in drug and biologics development\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\n\u003cul type=\"disc\"\u003e\n\u003cli\u003eClinical Trial Personnel responsible for collecting,\n     reviewing, and reporting investigational adverse events\u003c\/li\u003e\n\u003cli\u003eSafety Surveillance Personnel\n     responsible for the acquisition, classification, entry, analysis, and\n     reporting of adverse events in marketed products\u003c\/li\u003e\n\u003cli\u003eRegulatory Affairs Personnel\n     responsible for submitting safety reports to FDA and international\n     regulatory authorities\u003c\/li\u003e\n\u003cli\u003eQuality Control Personnel involved\n     in the investigation of adverse event reports\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp class=\"header-block-grey\"\u003eInstructor\u003cspan\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"bold-italic\"\u003eThe course will be led by one of the following\ninstructors:\u003c\/p\u003e\n\u003cp\u003eGlenda\nGuest, RQAP-GCP, C.C.R.A.\u003c\/p\u003e\n\u003cp\u003eMarla Hoelle, R.N., B.S.N.,\nC.C.R.A.-PM, P.M.P.\u003c\/p\u003e\n\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003cspan\u003e\u003ca href=\"https:\/\/stage.barnettinternational.com\/instructor-biographies\" title=\"Click here for complete trainer biographies\"\u003e\u003cspan\u003eClick here for complete trainer\nbiographies\u003c\/span\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"header-block-grey\"\u003eCourse Outline\u003c\/p\u003e\n\u003cp class=\"bold-italic\"\u003eDay One: 8:30 a.m. – 5:00 p.m.\u003c\/p\u003e\n\u003cul type=\"disc\"\u003e\n\u003cli\u003e\n\u003cspan class=\"bold\"\u003e\u003cspan\u003eIntroduction to AE Management and Reporting:\u003c\/span\u003e\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eBrief history of the FDA; pertinent historical\/ethical\n     perspectives; overview of pharmacovigilance\u003c\/span\u003e\u003cspan class=\"normal-text\"\u003e\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cspan class=\"bold\"\u003e\u003cspan\u003eClinical Trials:\u003c\/span\u003e\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eOverview of Regulations: FDA, ICH, EU, ISO; causality,\n     relatedness\/ expectedness, serious; sponsor reporting variations; FDA and\n     international expedited reporting; post-marketing clinical trial considerations;\n     reporting into IND; reporting into NDA; review of warning letters\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cspan class=\"bold\"\u003e\u003cspan\u003eUse of Electronic Records and Coding Concepts:\u003c\/span\u003e\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eElectronic records: regulations, considerations in your\n     environment, storage, submissions; MedDRA; SNOMED\u003c\/span\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp class=\"bold-italic\"\u003eDay\nTwo: 8:30 a.m. – 5:00 p.m.\u003c\/p\u003e\n\u003cul type=\"disc\"\u003e\n\u003cli\u003e\n\u003cspan class=\"bold\"\u003e\u003cspan\u003ePost-Marketing:\u003c\/span\u003e\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eOverview of FDA and international regulations; FDA and international\n      reporting requirements; labeling requirements;\n     product complaints\/quality control; review\u003c\/span\u003e\u003cspan class=\"normal-text\"\u003e\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cspan class=\"bold\"\u003e\u003cspan\u003eCombination Products:\u003c\/span\u003e\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eIntroduction to device regulations, definitions,\n     concepts; overview of Office of Combination Products; reporting\n     considerations for combination products\u003c\/span\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp class=\"header-block-grey\"\u003eInteractive Activities\u003c\/p\u003e\n\u003cul type=\"disc\"\u003e\n\u003cli\u003eRoutine Reporting in Clinical Trials\u003c\/li\u003e\n\u003cli\u003eUsing MedWatch for 15-Day Alerts\u003c\/li\u003e\n\u003cli\u003ePractice Using Coding Terminology\u003c\/li\u003e\n\u003cli\u003eReview of FDA Warning Letters in the\n     Clinical Trial Setting\u003c\/li\u003e\n\u003cli\u003eReview and Evaluation of FDA Warning\n     Letters in the Post-Marketing Setting\u003c\/li\u003e\n\u003cli\u003eAnalysis of AE Reports on\n     Combination Products\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\n\u003cp\u003eRegistration\nfees include assorted breakfast items that will be available each day ½ hour\nprior to the start of the seminar. Also included is a Networking Lunch that\nwill be served each training day.\u003c\/p\u003e\n\u003cp\u003eSpecial rates are available for\nmultiple attendees from the same organization. \nContact Melissa Dolen at 781-972-5418 to discuss your options and take\nadvantage of the savings.     \u003cspan\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003cspan\u003e\u003ca href=\"\/pages\/faqs\" title=\"Click here for our seminar cancellation policy\"\u003e\u003cspan\u003eClick here for our seminar\ncancellation policy\u003c\/span\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"header-block-grey\"\u003eAccreditation Information\u003c\/p\u003e\n\u003cp\u003eBarnett International is accredited by the\nAccreditation Council for Pharmacy Education as a provider of continuing\npharmacy education.  Participants will\nreceive 15 hours (1.5 CEUs) of continuing education credit for full\nparticipation, including the completion of a pre-test, post-test, and program\nevaluation.  Barnett International will\nissue a receipt of completion for earned CEUs within three weeks of program\ncompletion.  ACPE#: 0778-0000-19-034-L01-P.\nReleased: 11\/19. \u003c\/p\u003e\n\u003cp class=\"header-block-grey\"\u003e \u003c\/p\u003e\n\u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003e\u003cspan\u003eHold\nthis course at your company! For more information, contact Naila Ganatra at +1\n215.413.2471.\u003c\/span\u003e\u003c\/span\u003e\u003cb\u003e\u003cspan\u003e\u003c\/span\u003e\u003c\/b\u003e\u003c\/p\u003e","products":[],"url":"https:\/\/www.barnettinternational.com\/collections\/adverse-events-managing-and-reporting-for-pharmaceuticals.oembed","provider":"Barnett International ","version":"1.0","type":"link"}