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Strategic Review of Documents

Medical Writing Regulatory Topics

Day & Time:
March 11, 3:30PM - 5:00PM

Room Number:
Ballroom Salon I


Strategic Review of Documents

Darryl Zachary L'Heureux, PhD
Medical Writer
CSL Behring, United States

Document review is a critical component of drug development and must be executed from early clinical development to regulatory submission to post-marketing surveillance. The type of information and complexity that is found in these documents will vary with in the life cycle and range from single reports to a complex summation of all the known safety and efficacy data of the molecular entity. Different strategies may be implemented for reviewing documents but a common thread is woven throughout these review cycles. This session will discuss the need to understand the scope of the review, best practices to manage reviewers, and choice of appropriate vendors, tools, and platforms for the strategic review.

Learning Objective(s):
At the conclusion of this session, participants should be able to:
Identify different strategies and new methods for document review
Discuss staged reviews with focus on timely distribution to subject matter experts and timing to development stage
Utilize different tools (review instructions, checklists, content maps, work flow diagrams, and timelines) to enhance productivity of review cycles and document decision making

Presentation(s) & Speaker(s):
Darryl Zachary L'Heureux, PhD
Medical Writer
CSL Behring, United States

Challenges of the Review Process: Pitfalls and Best Practices
Ann M Winter-Vann, PhD
Senior Medical Writer and Consultant
Whitsell Innovations, Inc., United States

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