Course Description

The Common Technical Document (CTD) format is now the required format for all marketing applications in the U.S., EU, Japan, Canada, and Australia. Clinical Trial Applications (CTAs), the required format of INDs in most countries, are required to be in the CTD format. Currently, the U.S. does not require INDs to be in the CTD format, but rather the traditional format (per regulations in 21 CRF 312.23). However, since all marketing applications are required in the CTD format, it is more efficient to start the IND in the CTD format. If you use the traditional format, the IND and all amendment information must be converted to the CTD format prior to marketing application submission. This conversion time can impact the timeline for marketing application submission, so why not plan ahead for a successful marketing application and start the IND in the CTD format?

Currently, there is no guidance document to facilitate the transfer or mapping of information from the IND requirements contained in 21 CFR 312.23 to the CTD format. There is often a difference of opinion on where information should be stored. 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.

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Learning Objectives

• Describe the CTD and how and why it came into existence
• Describe the eCTD and basics tools for eCTD implementation
• Define a style guide and describe why it’s important for eCTD implementation
• Map the contents of the traditional IND to the CTD format

Who Should Attend

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

Instructor

Caroline Ritchie, Ph.D., M.B.A.

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