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 2020, 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.

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

Speaker Profile

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. 

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