CRED: Introduction to eCTD

eCTD Introduction

Overview

This one-day workshop features discussions on eCTD topics and comes with an eCTD Workshop Guide that is also a handy reference manual for future use. Participants will understand the history and benefits of eCTD, the global regulatory context, high-level technical aspects, structure and granularity of documents, and basics of file placement and document lifecycle, compilation and review, and more.
Introduction to eCTD is led by field-experienced trainers who have expert knowledge of eCTD and regulatory submissions.

Who Should Attend

This workshop is designed for all industry professionals with little to no experience with eCTD, who are presently, or planning to be, involved with the
development of eCTD submissions. This includes professionals in: Medical Writing, Regulatory Aff airs, Dossier and Document Management, IT and Data Management, Compliance, Publishing and Submission Management.

Workshop Learning Objectives

• Review the process that led to the development of the eCTD.
• Understand the global regulatory context for the eCTD.
• Gain a thorough understanding of eCTD concept and structure.
• Become familiar with the underlying XML technology used in the eCTD.
• Understand how the eCTD organizes study fi les, including Node Extensions, Study Tagging Files, and the regional requirements for datasets and case report forms.
• Learn about lifecycle management advantages of the eCTD.
• Get a glimpse into the challenges and logistics of submission logistics.
• Ask questions to an eCTD specialist.
• Exchange ideas with other participants.
• Receive detailed reference tables on the granular content of each section of a submission.

Topics include

• CTD/eCTD Basics.
• Submission Structure and Document Granularity.
• Hyperlinking and Templates.
• Technical Elements of the eCTD.
• Working with Study Files.
• Lifecycle Management
• Overview of the differences in guidance from different regulators