Course Description

All 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.

This 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.

Learning Objectives

• Describe CTD and CTD benefits
• Describe the eCTD and basic tools for eCTD implementation
• Use a style guide and describe why style is important for eCTD implementation
• Map contents of the traditional IND into the CTD format

Who Should Attend

• Regulatory Affairs Professionals
• Research and Development Professionals
• Manufacturing Personnel
• Clinical Research Professionals
• Medical Writers

Instructor

Joy Frestedt, Ph.D., C.P.I., R.A.C., F.R.A.C.P.

Click here for complete trainer biographies

Registration Fees

$735*

*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.

Accreditation Information

Barnett 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. 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.