2018 - Orchestrating a Successful eCTD

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 SHOULD YOU ATTEND
This webinar will provide you with information to ensure that you are ready for implementing the mandated requirements of the CTD/eCTD.
AREAS COVERED
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 format requirements
Discussion on the successful transition from other formats to the CTD
Implementing tools for the project management of CTD preparation and publishing
Technical requirements for an eCTD submission
Document naming requirements
Building the folder structure
Performing “pre-publishing” work for each document
Tools for tracking and managing eCTD content
Performing quality checks on the eCTD
Updating content in the CTD and eCTD (amendments, supplements, variations, etc.)
LEARNING OBJECTIVES
Get all the information needed for implementing the mandated requirements of the CTD/eCTD.
WHO WILL BENEFIT
Regulatory Affairs
Quality Assurance
Pharmacovigilance
Project Management
Regulatory Operations
Anyone responsible for providing content for the CTD
SPEAKER
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.
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