Introduction to eCTD
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| Date |
Location |
| February 21 |
Whippany, NJ |
| April 1 |
Whippany, NJ |
| May 19 |
San Francisco, CA |
| July 14 |
Whippany, NJ |
| August 18 |
Whippany, NJ |
| September 22 |
San Diego, CA |
| October 20 |
Whippany, NJ |
| October 23 |
London, England
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| December 1 |
Whippany, NJ |
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Workshop Length
Instructor-led 1-day workshop |
Note: To register for our workshops in EU, please click here. |
Cost
$995 / person; (Register for both the Introduction to eCTD and Advanced eCTD Concepts and Business Process Workshop and pay just $1749 / person for the two courses)
Overview
Designed for Life Science professionals, the Introduction to eCTD Workshop introduces new participants or participants with little experience to the fundamental concepts of eCTD. Participants will be led through clear step-by-step lessons based on case examples culled from years of successful submissions.
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 lead by field-experienced trainers who have expert knowledge of eCTD and regulatory submissions. Our trainers have presented at industry conferences, authored publications and written courses and textbooks on eCTD and other industry topics. With over 400 successful eCTD submissions, ISI is committed to passing on field-tested experience and best practices to workshop participants.
Workshop Details
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 an eCTD submission. This includes professionals in: Medical Writing, Regulatory Affairs, Dossier and Document Management, IT and Data Management, Compliance, Publishing and Submission Management.
Prerequisite
This course is not a prerequisite to Advanced eCTD Concepts and Business Process, however, this course is recommended if you have little to no experience with eCTD before taking the next level.
Workshop Materials
Along with the knowledge that will be acquired from this workshop, an Introduction to eCTD Workshop Workbook is provided. Following the same structure as the workshop, the Workbook is filled with industry-sensitive information and also provides references to many of the guidance documents developed by the FDA and the web addresses to access them.
Workshop Learning Objectives
After attending this workshop participants will have had the opportunity to:
- Review the process that led to the development of the eCTD.
- Understand 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 files, including Study Tagging Files, 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.
Lesson Topics
CTD/eCTD Basics
This lesson provides a brief history of the harmonization and inception of the ICH. A review of the ICH process to develop the five modules of the CTD is followed by a high-level look at the structure for each of the modules. The lesson closes with an introduction to the elements of the eCTD, including XML, DTD and XSL.
Submission Structure and Document Granularity
This lesson takes the modules of an eCTD down to the next level of detail. It describes the folder structure used by the eCTD and defines each level. Modules are described in text and through illustrations of the folder structures. The lesson then delves into mapping from the NDA, BLA and IND structure to the eCTD structure. Also demonstrated is the relationship between modules and hyperlinking possibilities used in an eCTD to navigate between the documents.
Hyperlinking and Templates
The benefits of using templates to author each granular document are discussed in detail in this lesson. Also included are helpful examples of what to hyperlink in a CTD, and suggestions on the most efficient time in the process to create the hyperlinks.
Technical Elements of the eCTD
The information technology elements of the eCTD (XML, HTML, XSL and DTD) are described clearly for anyone to understand the concepts, but with enough detail for technical personnel to understand how the eCTD works. This lesson breaks down the technical elements by submission level and document level, in addition to what is required by the ICH and regulatory agencies (eg, metadata, file formats, file requirements, path requirements, leaf IDs, operation attributes, check sum and xlink:HREF). Additional technical elements included with this lesson are SPL, PIM and CDISC.
Working with Study Files
Explore the methods that the eCTD uses to view the files that are related to specific studies. What are study tagging files, datasets and case report forms? How are they created? How can they be viewed? All of these questions will be discussed and answered.
Lifecycle Management
This lesson analyzes the various lifecycles that are associated with an eCTD. These are submission lifecycle, document lifecycle, and cumulative and accumulative Study Tagging Files.
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