Overview
The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) 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 increased efficiency for reviewers and improved submission times. Beginning in May 2017, the eCTD will be required in the US for all marketing applications.
Why you should attend
This webinar will provide you with information to ensure that you are ready for implementing the mandated requirements of the CTD/eCTD. This webinar will provide you with information to ensure that you are ready for implementing the mandated requirements of the CTD/eCTD.
Webinar Takeaway
Lecture 1 - CTD > eCTD
Overview of the drug development program and source of relevant submission documents
Discussion of the roles and responsibilities for CTD preparation
Review of the CTD content & format requirements
Implementing tools for the project management of CTD preparation and publishing
Lecture 2 - eCTD Prepararation
Technical requirements for an eCTD submission
Document naming requirements
Building the folder structure
Publishing each document, module & submission
Tools for tracking and managing eCTD content
Performing quality checks on the eCTD
Lifecycle management: Updating content (amendments, supplements, variations, etc.)
Who will Benefit
- Regulatory Affairs
- Quality Assurance
- Pharmacovigilance
- Project Management
- Regulatory Operations
- Anyone responsible for providing content for the CTD
Industries who can attend
This 360 -minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.
Faculty Peggy J. Berry
Peggy J. Berry, MBA, RAC, is the President & 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, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014).
