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DIA 2021 Global Annual Meeting

Improving Efficiency and Quality of Regulatory Documents

Session Chair(s)

Mark R Bowlby, PhD

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)

Mark R Bowlby, PhD

The Trend Toward Collaborative Authoring: Pros and Cons Versus Fixed Steps for Document Development

Mark R Bowlby, PhD

  • Director, Global Submissions
  • Synchrogenix, A Certara Company, United States
Mitali Purohit, PhD, MS

CTD Submission Paradigm

Mitali Purohit, PhD, MS

  • Associate Director
  • CSL Behring, United States