{"product_id":"medical-writing-fundamentals-how-to-write-regulatory-documents-2026-08-11","title":"Medical Writing Fundamentals: How to Write Regulatory Documents","description":"\u003cp\u003e \u003c\/p\u003e\n\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\n\u003cp\u003eMedical writing has its own standard practices and idiosyncrasies. Knowing what to write, how to format, and how to navigate corporate processes can require a big learning curve. This web seminar will give learners an overview of writing practices, formatting, working with tables\/figures, and communicating effectively. Practical applications of these skills will be described as they apply to writing all types of documents for submission to global regulatory authorities, including protocols, clinical study reports, investigator’s brochures, data management plans, statistical analysis plans, documents for modules in the Common Technical Document (CTD) format, and briefing books. Real-life examples of strategies for generating a great document by understanding the what and why of the different documents will also be presented.\u003c\/p\u003e\n\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\n\u003cul type=\"disc\"\u003e\n\u003cli\u003eReview basic medical writing skills, including correct abbreviation practices, consistent captioning, and table generation\u003c\/li\u003e\n\u003cli\u003eUtilize styles and templates\u003c\/li\u003e\n\u003cli\u003eDescribe style guides and their importance\u003c\/li\u003e\n\u003cli\u003eDescribe the communication process needed for document review and completion\u003c\/li\u003e\n\u003cli\u003eConduct a literature search\u003c\/li\u003e\n\u003cli\u003eApply these skills to all regulatory documents\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\u003eNew Medical Writers\u003c\/li\u003e\n\u003cli\u003eClinical Research Professionals (i.e., CRAs, Data Managers)\u003c\/li\u003e\n\u003cli\u003eStatisticians\u003c\/li\u003e\n\u003cli\u003eStudy Coordinators\u003c\/li\u003e\n\u003cli\u003eDocument Signatories (i.e., Chief Medical Officers, Clinical Pharmacologists)\u003c\/li\u003e\n\u003cli\u003ePersonnel who review regulatory documents or are involved with investigator-sponsored studies\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\n\u003cp\u003eJoy Frestedt, Ph.D., C.P.I., R.A.C., F.R.A.C.P.\u003c\/p\u003e\n\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\n\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\n\u003cp\u003e$735*\u003c\/p\u003e\n\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\n\u003cp class=\"header-block-grey\"\u003eAccreditation Information\u003c\/p\u003e\n\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#: 0778-0000-23-071-L99-P. Released: 8\/23.\u003c\/p\u003e\n\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 \u003cspan style=\"color: black; font-family: Verdana, Arial, Helvetica, sans-serif;\"\u003e \u003c\/span\u003e\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53375390187885,"sku":"BI17364","price":735.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/medical-writing-fundamentals-how-to-write-regulatory-documents-2026-08-11","provider":"Barnett International ","version":"1.0","type":"link"}