Comply with eCTD Submissions of IND/NDA to the U.S. FDA Before May 5, 2018

Event Information
Product Format
Prerecorded Event
Peggy J. Berry, MBA, RAC
Conference Date
Fri, Jan 19, 2018
90 minutes
Product Description

Prepare to Implement the FDA’s Regulations for eCTD Submissions of IND/NDA Before May 5, 2018

The international agreement to assemble all quality, safety and efficacy information for a drug or biologic product into a common format—common technical document (CTD)—has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies. Reformatting for multiple submissions is also substantially limited. The CTD has improved the regulatory review processes and enabled implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times.

Since May 2017, the eCTD is required in the U.S. for all marketing applications. Recently the FDA has extended the deadline for filing master files and all documents submitted to existing master files, in the electronic Common Technical Data (eCTD) format from May 5, 2017 to May 5, 2018.

Join this session, where consulting expert, Peggy J. Berry, MBA, RAC, will provide you with the information to ensure that you are ready for implementing the mandated requirements of the CTD/eCTD.

Session Highlights

This session will discuss:

  • The drug development program and source of relevant submission documents
  • The roles and responsibilities for CTD preparation
  • The CTD format requirements
  • Successful transition from other formats to the CTD
  • How to implement tools for the project management of CTD preparation and publishing
  • Technical requirements for an eCTD submission
  • Document-naming requirements
  • How to build the folder structure
  • How to perform “pre-publishing” work for each document
  • The tools for tracking and managing eCTD content
  • How to perform quality checks on the eCTD
  • How to update content in the CTD and eCTD (amendments, supplements, variations, etc.)

Who Should Attend

  • Regulatory affairs
  • Quality assurance
  • Pharmacovigilance
  • Project management
  • Regulatory operations
  • Anyone responsible for providing content for the CTD

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Peggy J. Berry

Peggy J. Berry, MBA, RAC, is the president and CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, Peggy was Vice President of Regulatory Affairs at Insmed where she was responsible for the development and implementation of...   More Info
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