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Improving Efficiency and Quality of Regulatory Documents
Session Chair(s)
Mark R Bowlby, PHD
Director, Global Submissions
Synchrogenix, A Certara Company, United States
Document development for eCTD submission is a long and complex endeavor. The near-universally adopted method for document development, namely, the draft-review-revise process, is increasingly being questioned as best practice. This session will explore collaboration efforts and other options to improve the efficiency and quality of regulatory document authoring and editing.
Learning Objective : Describe how submission documents are organized in the eCTD structure; Identify how to develop summary documents in a collaborative team structure, and technical options for collaborative authoring and revising of documents.
Speaker(s)
The Trend Toward Collaborative Authoring: Pros and Cons Versus Fixed Steps for Document Development
Mark R Bowlby, PHD
Synchrogenix, A Certara Company, United States
Director, Global Submissions
CTD Submission Paradigm
Mitali Purohit, PHD, MS
CSL Behring, United States
Associate Director, Immunology TA Lead