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.)
This session will cover:
Who Should Attend
- Dr. David Lim
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...
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