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.

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

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

For more detail please click on this below link:
https://bit.ly/2GfpovI

Email: [email protected]
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882

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