100+ Clinicalstudy reports quality module PowerPoint (PPT) Presentations, Clinicalstudy reports quality module PPTs

Clinicalstudy reports quality module - PowerPoint PPT Presentation

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

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1.13k views • 23 slides

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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399 views • 23 slides

Preparing the Quality Overall Summary in the New Paradigm

Preparing the Quality Overall Summary in the New Paradigm. Michelle Herrera Foster, Ph.D. Regulatory Affairs Consultant CTD Quality Consulting. Topics. What is a Quality Overall Summary (QOS) Regulatory Evolution The New CMC Paradigm QOS as a Key Reviewer Tool QOS Pitfalls QOS Keys

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549 views • 18 slides

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'Clinicalstudy reports quality module' presentation slideshows

Clinicalstudy reports quality module - PowerPoint PPT Presentation

CTD Content Management

CTD Documents as Key Reviewer Tools

Preparing the Quality Overall Summary in the New Paradigm