{"product_id":"the-ind-in-a-ctd-ectd-format-2026-08-10","title":"The IND in a CTD\/eCTD Format","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eAll marketing applications in the US, EU, Japan, Canada and Australia require submissions to follow the Common Technical Document (CTD) format. Clinical Trial Applications (CTAs), the required format of INDs in most countries, are also required to be in the CTD format. Currently, the US requires INDs to be in the CTD format for all commercial INDs, but the traditional format per regulations in 21 CRF 312.23 is still used for academic IND applications.\u003c\/p\u003e\u003cp\u003eThis course will review the FDA regulations and guidance documents to facilitate the mapping of information from the IND requirements contained in 21 CFR 312.23 to the CTD format. This web seminar will give an overview of the IND requirements and where they can most effectively \"fit\" into the CTD requirements for a streamlined FDA review and building of the IND into a marketing application. \u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eDescribe CTD and CTD benefits\u003c\/li\u003e \u003cli\u003eDescribe the eCTD and basic tools for eCTD implementation\u003c\/li\u003e \u003cli\u003eUse a style guide and describe why style is important for eCTD implementation\u003c\/li\u003e \u003cli\u003eMap contents of the traditional IND into the CTD format\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\u003eResearch and Development Professionals\u003c\/li\u003e \u003cli\u003eManufacturing Personnel\u003c\/li\u003e \u003cli\u003eClinical Research Professionals\u003c\/li\u003e \u003cli\u003eMedical Writers\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 href=\"https:\/\/stage.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\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e$735*\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 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#: 0778-0000-23-060-L99-P. Released: 8\/23. \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":53375390450029,"sku":"BI17360","price":735.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/the-ind-in-a-ctd-ectd-format-2026-08-10","provider":"Barnett International ","version":"1.0","type":"link"}