eCTD 301: eCTD Readiness Workshop

Course Description
Designed for Life Science professionals, the eCTD Readiness Workshop educates participants on the basics and details of the CTD and eCTD. The workshop begins with a brief history of the ICH and the global regulatory context for eCTDs. It then continues with details on document granularity, application and document lifecycle, study files, hyperlinking document content, PDF requirements, electronic submission logistics and more.

Throughout the course of the workshop, discussions will be held on topics such as, the advantages and disadvantages of the eCTD, how to overcome the disadvantages, process and procedure changes you may need to implement, and common issues encountered by regulatory agencies with submissions that have been received.

Who Should Attend
This workshop is designed for all industry professionals who are presently, or planning to be involved, with the development of an eCTD submission. This includes project managers, medical writers, regulatory affairs specialists, business analysts, IT professionals and documentation specialists.

Prerequisites

• Knowledge of existing business processes
• Basic knowledge of regulatory submissions process a plus, but not required

Course Length
Two days.

Topics Covered

• CTD/eCTD Basics
• Technical Elements of the eCTD
• Submission Structure and Document Granularity
• Working with Study Files
• Lifecycle Management
• Submission Strategies: Hyperlinking, Templates and More
• Submission Logistics for Paper, Electronic and Hybrids
• Regulatory Requirements
• eCTD Readiness Assessment