Industries: Pharma / Biotech

The Electronic Common Technical Document (eCTD): Strategies & Tools to Build a Successful Submission

 

Course Description - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)

The guidance on marketing applications for drugs and biologics, known as the Common Technical Document (CTD), was finalized by the International Conference on Harmonization (ICH) in 2003. Today the CTD format is highly recommended for marketing applications in the United States, and is mandatory in other regions, including Canada, Japan, and Europe.

The eCTD format has become mandatory in key markets for electronic submissions. Since January 2010, the European Medicines Agency has required all applications in the centralized procedure use the eCTD format. In the US, the eCTD format has become a requirement for all New Drug Applications, Biologics License Applications and Abbreviated New Drug Applications following the 2012 reauthorization/update of the Prescription Drug User Fee Act (PDUFA). Further, the Generic Drug User Fee Act and Medical Device User Fee Act also impose mandatory electronic submissions to FDA.

This course, while focusing on the US requirements, also provides a quick overview of current regulatory guidelines of eCTD in major world market including North America, the European Union, and Asia-Pacific. It aims to introduce tools to assist the participants in formulating effective strategies in the development, compilation, and submission of US-compliant eCTDs. The structure of the eCTD, its content and granularity for the modules will be introduced, along with a review of the specifications, scope, requirements for the architecture and functionalities, as well as its impact on the pharmaceutical industry. .

Through practical workshop exercises, interactive discussions and real-life case studies, this training aims to provide useful tools for the participants to build eCTDs from the ground up. Advice on industry's best practice, as well as submission pitfalls from the reviewer's perspective will be introduced to help the participants in formulating the best strategies and employing the most practical tools to enhance the success of their electronic submissions.

Who Should Attend

This course is designed for professionals of the biotechnology and pharmaceutical industries who are currently, or planning to become, involved in the development of regulatory submissions using the electronic Common Technical Document (eCTD). The program is particularly suitable for project team members interested in gaining a practical understanding of regulations, tools, and required submission processes. This includes professionals working in:

  • Regulatory Affairs / Regulatory Operations
  • Submissions Management
  • Authors of CTD Sections
  • Technical and Clinical Writers
  • Documentation Teams
  • Project Management
  • Information Technology and Information Systems

Course Agenda

First Day

Session 1: Introduction and Overview

  • About market authorization & electronic submission around the world
    • Regulatory background
    • Authorization procedures
    • Submission standards
    • Assessment procedures
    • Mutual recognition
       
  • eCTD today
    • CTD & ICH
    • Historical & legislative overview
    • Who is doing what, where, how
    • Global implementation status

Session 2: eCTD Fundamentals – the Basics

  • Overview of eCTD
    • eCTD basics and terminology
    • eCTD architecture
      • The XML backbone
        • File formats
        • XML specification
        • Document type, definition, attributes, etc.

Session 3: eCTD Fundamentals – Dossier Preparation

  • eCTD hierarchy
    • Structure
    • Organization
    • Specifications
    • Modularity
       
  • Compilation of regulatory submissions
    • What is submission ready
    • Documents & templates
    • Document logistics
    • Document control
    • Document granularity
       
  • Bookmarks, hyperlinks, cross-references, etc.

Session 4: eCTD Review & Validation

  • Overview of the regulatory review process
     
  • Technical validation process & requirements
    • Validation criteria
    • Tools
    • Interpretation
    • Common errors

Second Day

Session 5: Workshop – Building a submission based on eCTD format

  • Group exercise
     
  • Case studies
    • The dreaded Refuse to File (RTF)
    • Best practice - document authoring
    • Becoming eCTD-compliant
    • Challenges & issues
       
  • Submission planning & strategy

Session 6: eCTD Lifecycle Management

  • Getting to know the eCTD lifecycle
     
  • Change management of an evolving dossier
    • Did we capture all?
    • How to manage obsolescence?
  • Document control & tracking
     
  • Get the right tools and/or the right partners

Session 7: Workshop – eCTD Lifecycle Management

Session 8: Global Comparison & Contrast

  • Regional Requirements in key world market: United States, Canada, Asia-Pacific and the European Union (Centralized Procedure)
  • Global submission planning & coordination
  • Tools & strategies

Learning Objectives

Upon completion of this course, participants will be able to:

  • Understand the history and legislative background of eCTD and electronic submissions around the world
  • Develop plans for the compilation of compliant eCTD submissions
  • Identify processes employed in preparing CTD/eCTD submissions
  • Understand the basics of correct eCTD format and requirements to generate submission-ready documents
  • Identify & access tools and technology used in preparation and review of eCTDs
  • Identify potential problematic areas through practical workshop team projects & real life case studies
  • Compare and contrast regional specificities pertaining to the requirements for electronic submissions in a global market

Testimonials

"The Course Director was great- knowledgeable and engaging! She was energized and funny and kept us laughing. Definitely recommend her!." Gretchen G., Submission Coordinator, Cutanea Life Sciences
"The Course Director was a great instructor! Engaging, funny, and extremely knowledgeable." Nicole B., Regulatory Chemist, Zevacor Molecular
"The Instructor is a very experienced professional. He has an in-depth knowledge of the eCTD structure and process which is very relevant in the industry." Tina S., Reg. Project Manager, BioMarin Pharmaceuticals, Inc.
"The size of the class really made a huge difference when it came to the needs of each attendee. It allowed the Course Director to answer questions more thoroughly, to interact with us, and encourage us to interact more. The Course Director was organized and open to discussion, which allowed us to communicate with him in a friendly but professional manner." Rebecca H., Sr. Doc. Coor. Reg. Affairs, Teva Pharmaceuticals
"Very thorough presentation. Excellent handouts" Donna B., Director Medical Writing, Sepracor
"This course was excellent! The Course Director did a nice job of presenting all the material." Michele C., Senior Regulatory Assoc., Par Pharmaceuticals
"The Instructor covered a great deal of material in two days and was very knowledgeable on many aspects of FDA Inspections. I would recommend this course to my colleagues." David M., Director, Bayer
"The Course Director had a wealth of knowledge to share along with a good deal of practical experience." Data Management, Merck
"Course content was excellent! It provided a fundamental understanding of the regulatory process." Tara M., Regulatory & Compliance Supervisor, Pfizer
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