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CTD Documents as Key Reviewer Tools

CTD Documents as Key Reviewer Tools. Michelle Herrera Foster, Ph.D. Senior Regulatory Consultant. Objectives. Explore how Common Technical Document (CTD) documents can serve as key reviewer tools, to meet the needs of the agency reviewers and internal reviewers

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CTD Documents as Key Reviewer Tools

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  1. CTD Documents as Key Reviewer Tools Michelle Herrera Foster, Ph.D. Senior Regulatory Consultant

  2. Objectives • Explore how Common Technical Document (CTD) documents can serve as key reviewer tools, to meet the needs of the agency reviewers and internal reviewers • Introduce key authoring tools and processes for submission-ready documents • Present the CTD as a development tool

  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. What do the Reviewers Need? • Clear Conclusions • Backed-up Justifications • Risk Assessment • Data summaries • A framework for navigating the entire CTD • Reasons to approve your drug • Succinct, easy to review documents – Summaries are key!

  5. CTD Summaries – Module 2 2.3 The Quality Overall Summary 2.4 The Nonclinical Overview 2.5 The Nonclinical Summary 2.6 The Clinical Overview 2.7 The Clinical Summary

  6. Module 2 Summaries • Summaries of Modules 3-5 • Content linked to Modules 3-5 • Summary of primary data, conclusions, rationales, and risk assessment • Content of one summary integrated with the others • Explanations of any guideline deviations

  7. 2.3 Quality Overall Summary • 40-80 pages • Gives the reviewer an understanding of how the formulation and manufacturing process affects product quality and performance (safety and efficacy). • Focuses on critical quality attributes (CQA) and critical manufacturing parameters • Risk-based and science-based rationales (GMP Initiative, ICH Q8-10)

  8. 2.4 Nonclinical Overview • 30 pages • Integrated critical assessment of the pharmacology, pharmacokinetics, and toxicology evaluations • Addresses: • Adherence to guidance, justification of strategy • GLP status • Safety for intended clinical use • Safety of impurities

  9. 2.6 Nonclinical Written and Tabulated Summaries • 100 – 150 pages • Written summary of comprehensive factual synopsis of the nonclinical data • Tabulated summaries using table formats in ICH M4 Safety

  10. 2.5 Clinical Overview • 30 pages • Critical analysis, succinct discussion, with conclusions and implications • Addresses: • Strengths and limitations of study results • Benefits and risks of the drug • Support of prescribing information

  11. 2.7 Clinical Summary • 50 - 400 pages • Detailed factual summarization of the clinical information • Summarizes: • Individual clinical study reports • Cross-study analyses • Postmarketing data • Table formats in ICH M4 Efficacy

  12. Pitfalls of Summaries • A dump of module 3-5 data • No critical assessment • Lack of rationales • No integration with other summaries • Poor organization and presentation • Just a regulatory requirement

  13. 5 Keys for Summaries To help us: • Assist the preparation • Facilitate review • Expedite approval

  14. Key #1Be Succinct • High-level data summaries and conclusions • Focus on key messages • Focus on critical attributes and parameters • Provide clear rationales • Provide useful context • Give the reviewers what they need to know to approve your product!

  15. Key #2Provide Rationales • Justify study designs, methodology, deviations, and acceptance criteria • Reference agency agreements • Conclusions must have a logic trail • Don’t wait for a deficiency question before providing justifications

  16. Key #3Bottom Line Up Front (BLUF) • Conclusions First - Don’t make the reviewer wade through paragraphs to find out the bottom line • Describe key issues and their resolutions • Address key deviations from guidance • Organize the information so that it is easy to follow and understand

  17. Key #4Address key agency trends • New guidance • Recent approvals • New technologies • Risk-based review • Consider Question-Based Review, e.g. “How was your product designed to meet your defined critical attributes?”

  18. Key #5Link to Modules 3-5 • Be consistent with modules 3-5 • Cross-reference and hyperlink to modules 3-5 • Make it easy for your reviewers to find the data supporting key messages in the summaries

  19. CTD Summaries asKey Reviewer Tools • To expedite marketing approval • Management approval of the “bottom line” • Development Plan, TPP, strategy • Pre-meeting package • Gap analysis • Project management, Submission tracking • Enhanced cross-functional communication

  20. Key CTD Needs and Tools

  21. CTD-Ready Reports Key results, conclusions For QOS Summary Summary of methods Module 3 data Body of Report Figures, graphs Discussion Raw data GMP Info Appendices May not be submitted, on file Protocols

  22. Conclusions • CTD Summaries are key tools for agency review • Summaries can be the basis for internal planning, review, and tracking • Summaries should assess risk and provide scientific rationales • CTD-ready documents enhance efficiency throughout development • Meeting the reviewers’ needs will help you meet your own needs, i.e. approval!

  23. Speaker Contact Michelle@ctdquality.com 978-356-0872 www.ctdquality.com

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