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Wednesday, June 30 • 4:00pm - 5:00pm
#354 SL: Improving Efficiency and Quality of Regulatory Documents

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-629-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.

Chair

Mark R Bowlby, PhD

Speaker

The Trend Toward Collaborative Authoring: Pros and Cons Versus Fixed Steps for Document Development
Mark R Bowlby, PhD

CTD Submission Paradigm
Mitali Purohit, PhD, MS



Speakers
MP

Mitali Purohit

Associate Director, CSL Behring, United States
MB

Mark Bowlby

Director, Global Submissions, Synchrogenix, A Certara Company, United States
Dr. Bowlby has over 24 years of experience in the clinical research and drug development industry. During the last 10 years, he has led many NDA, BLA, and IND submissions to the FDA and EMA. Dr. Bowlby has held many lead writing roles for IBs, CSRs, clinical summaries and overviews... Read More →


Wednesday June 30, 2021 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  04: MedAffairs-SciComm, Session