1 / 23

CTD Content Management

CTD Content Management. Michelle Herrera Foster, Ph.D. Regulatory Affairs Consultant. Objectives. To present the use of the CTD/eCTD as a tool for content and document management throughout development to meet the goal of marketing approval and maintenance

bernad
Download Presentation

CTD Content Management

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. CTD Content Management Michelle Herrera Foster, Ph.D. Regulatory Affairs Consultant

  2. Objectives • To present the use of the CTD/eCTD as a tool for content and document management throughout development to meet the goal of marketing approval and maintenance • To discuss meeting the needs of the development program with effective use of submission-ready documents, document management, and workflow processes. • Examples from Module 3 will be presented.

  3. Module 2 NonclinicalOverview ClinicalOverview NonclinicalSummary ClinicalSummary NonclinicalStudy Reports ClinicalStudy Reports Quality Module 3 Module 4 Module 5 ICH M4 NOT Part of the CTD RegionalAdminInformation Module 1 The CTD QualityOverallSummary

  4. The Common Technical Document (CTD) • Required in EU, Japan, and Canada for marketing applications • “Highly recommended” by FDA for NDA, BLA: • FDA follows ICH guidance • Good Guidance Practices (9/00) require that CTD not be mandatory • Required by CDER for eCTD submissions • Required in EU (IMPD) and Canada for investigational applications; accepted by FDA for IND

  5. DRM Needs in CTD Preparation • Manage filing of information for ready accessibility by contributors, authors, and reviewers from IND to NDA • Develop shared databases in submission-ready templates, e.g. stability data • Agree on standards for terminology, product names, cross-references, etc. • Meet Quality standards and traceability to source documents; Quality Systems • Define content early to prepare and expand/update submission-ready documents throughout development (IND to NDA)

  6. Module 2 NonclinicalOverview ClinicalOverview NonclinicalSummary ClinicalSummary NonclinicalStudy Reports ClinicalStudy Reports Quality Module 3 Module 4 Module 5 From IND to NDA NOT Part of the CTD RegionalAdminInformation Module 1 Phase 1: Focus on Safety NDA: Complete Details The CTD QualityOverallSummary

  7. Module 2 NonclinicalOverview ClinicalOverview NonclinicalSummary ClinicalSummary NonclinicalStudy Reports ClinicalStudy Reports Quality Module 3 Module 4 Module 5 From IND to NDA NOT Part of the CTD RegionalAdminInformation Module 1 Introduce Protocols and Study Reports at each phase The CTD QualityOverallSummary

  8. Building the NDA from Phase 1 P.1 P.2 P.3 P.4 P.5 P.6 P.7 P.8 S.1 S.2 S.3 S.4 S.5 S.6 S.7 Development Plan Pre-IND IND NDA, DMF Post-Approval

  9. Marketing Goals: the NDA • Label Claims, Target Product Profile • Clinical Studies that support the label • Nonclinical Studies that support the clinical plan • CMC Data for the commercial product • Meet regulatory guidelines, standards, and agreements for approval • Set your strategy with CTD summaries (Module 2)

  10. Why CTD content management? • Global harmonization of submission content (regional differences are handled in a modular fashion) • Standardization of submission format from clinical to marketing; from IND to NDA • Allows for preparation of submission-ready document templates • Facilitates life cycle management

  11. Submission-Ready Documents • Build the marketing application from Ph 1 to NDA and post-marketing • The modular approach to writing submissions; capture regional differences • Each section/attachment is a technical report, or a section within the report • Meet eCTD granularity rules; eCTD-ready • More efficient use of resources, expedites submissions, less cost and stress to the organization

  12. Levels of Submission-Ready Reports (Module 3) Key results, conclusions For QOS Summary Summary of methods Module 3 data Body of Report Key Tables, Figures, Graphs Discussion Complete data GMP Info Appendices May not be submitted, on file Protocols

  13. CTD/eCTD Templates • Define content and format for each section/report, granularity for eCTD • IND  NDA content for use throughout the development process; gap analysis • Address CTD, ICH, agency guidance • Address agency agreements • Customized for each product • May be expanded into model reports

  14. Why CTD Document Management? • The world revolves around regulatory (!) • Product approval and regulatory compliance are highest priorities • Now there is global standardization; no excuse not to “file” according to the CTD • Shared databases enhance communication, transparency, efficiency, and co-operation • Quality Systems requirements (ICH Q10)

  15. Shared Info and Databases Example: Control of Drug Product: • 3.2.P.5.1 Specifications • 3.2.P.5.2 Analytical Procedures • 3.2.P.5.3 Method Validation • 3.2.P.5.4 Batch Analysis • 3.2.P.5.5 Characterization • 3.2.P.5.6 Justification of Specifications

  16. CTD Mapping • Map source documents and related data to each section of the CTD • For example: 3.2.P.5.4 Batch Analysis: • Certificates of Analysis • Raw data: chromatograms, etc. • Statistical analyses • Trend analyses • Batches in each phase of development • Information on batches • Get management approval of the MAP

  17. Batch # Mfg Date Mfg Site Batch Size Process Intended Use Clinical Clinical studies Commer-cial Stability studies Description of Batches

  18. Key CTD Needs and Tools

  19. The CTD Team • Set submission strategy • Define submission content • Author standardized documents • Make documents accessible • Work with the extended team: • Regional offices • Business partners • Contract manufacturers, other contractors

  20. CTD Workflow CTD, eCTD Workflow Document Management Submission-Ready Documents Content Management

  21. Start Early in Development • CTD Content Management: • Templates from IND to NDA • Submission-Ready documents • CTD Document Management • CTD Mapping • CTD Repository, filing strategies • Get Management Approval up front • Get CTD Team ready from the start • Put this in everyone’s Objectives

  22. Conclusions • Merge document management and submission management to align marketing goals early in development • This promotes clear communication, transparency, and teamwork • Submission-ready documents written with CTD/eCTD templates from IND to NDA enhance efficiency • CTD document management facilitates traceability in quality systems

  23. Contact Information Michelle Herrera Foster, Ph.D. CTD Quality Consulting Michelle@ctdquality.com 978-356-0872 www.ctdquality.com NOTE: Survey of CTD/eCTD needs and solutions for module 3 in progress.

More Related