{"product_id":"writing-and-updating-the-investigator-s-brochure-2026-12-11","title":"Writing and Updating the Investigator's Brochure","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eDuring the course of clinical research, the Investigator's Brochure (IB) is the data repository for an investigational product; effectively this is the product's \"label\" during the investigational stage. The IB is a dynamic document which changes as the information changes. It is critical in clinical research as physicians and Institutional Review Boards (IRBs) refer to the IB on an ongoing basis to answer questions about Serious Adverse Events, Adverse Events, dosing, manufacturing, and clinical and nonclinical study results. To facilitate the transfer of information, the IB must be concise, well-written, and provide a summary for a physician to quickly reference. ICH GCP E6 Guideline provides an outline of the requirements, how companies address these requirements and the degree of information provided differs. The required contents will be reviewed in this web seminar. Tips and techniques for effective writing, including pulling together the needed information, working with a team, and writing a summary will also be discussed. \u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eIdentify who contributes to the IB\u003c\/li\u003e \u003cli\u003eDetermine the timing of construction of the IB\u003c\/li\u003e \u003cli\u003eList IB requirements per the ICH GCP E6 Guideline and effectively implement these requirements\u003c\/li\u003e \u003cli\u003ePerform a research literature review for the background section, and reuse it in other documents\u003c\/li\u003e \u003cli\u003eExamine how a Target Product Profile or Draft Package Insert can be drafted based on the IB\u003c\/li\u003e \u003cli\u003eExamine approaches that support physician's reading of the IB: The IB Summary\u003c\/li\u003e \u003cli\u003eDetermine when the IB should be updated, by whom, and what documents the update effects\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eRegulatory Affairs Professionals\u003c\/li\u003e \u003cli\u003eMedical Writers\u003c\/li\u003e \u003cli\u003eClinical Research Professionals\u003c\/li\u003e \u003cli\u003eResearch and Development Personnel\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp\u003eJoy Frestedt, Ph.D., C.P.I., R.A.C., F.R.A.C.P.\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\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e$835*\u003c\/p\u003e\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\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 2 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. ACPE#: 0778-0000-24-031-L99-P. Released: 3\/24. \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 \u003cfont color=\"black\" face=\"Verdana, Arial, Helvetica, sans-serif\" size=\"-1\"\u003e \u003c\/font\u003e \u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53375366431085,"sku":"BI17585","price":835.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/writing-and-updating-the-investigator-s-brochure-2026-12-11","provider":"Barnett International ","version":"1.0","type":"link"}