eCTD Submissions Requirement of IND/NDA to the U.S. FDA

eCTD Submissions of IND/NDA to the U.S. FDA

Event Information
Product Format
Prerecorded Event
Presenter(s)
Peggy J. Berry, MBA, RAC
Length
90 minutes
Product Description

Learn to Implement the Mandated Requirements of the CTD/eCTD


The international agreement to assemble all quality, safety and efficacy information for a drug or biologic product into a common format—called the 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 substantially limited.

The CTD has improved the regulatory review processes and enabled implementation of good review practices. The eCTD has further increased efficiency for reviewers and improved submission times. Since May 2017, the eCTD is required in the U.S. for all marketing applications.

Join this session, where drug development and regulatory affairs expert Peggy Berry will provide you with the information to ensure that you are ready for implementing the mandated requirements of the CTD/eCTD. You will learn about the technical requirements for an eCTD submission, and get tools for tracking and managing eCTD content.  You will also learn how to update content in the CTD and eCTD (amendments, supplements, and variations, etc.)

Session Highlights

This session will cover:

  • The drug development program and source of relevant submission documents
  • The roles and responsibilities for CTD preparation
  • The CTD format requirements
  • The 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
  • 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, and variations, etc.)

Who Should Attend

  • Regulatory affairs personnel
  • Quality assurance personnel
  • Pharmacovigilance personnel
  • Project management personnel
  • Regulatory operations personnel
  • Anyone responsible for providing content for the CTD
You can also order through:
Phone

1-866-458-2965

Fax

1-919-287-2643

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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