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Session Chair(s)
Nancy Katz, PHD
President
Illyria Consulting Group, Inc., United States
Learning Objective : Explain how to write for a regulator; Describe how to establish, lead, and/or support team members of an eCTD-based submission team who are writing clinically focused Module 2 summaries; Describe the deliverables required from each new team member.
Speaker(s)
Memorable and Compelling Writing for eCTD Documents
Meredith Brown-Tuttle, RAC
Crinetics Pharmaceuticals, Inc., United States
Regulatory Affairs
The Well-Oiled Team: Playing Your Position from SAS Output Through Quality Assurance Audit to Create Reviewer-ready Regulatory Documents
Nancy Katz, PHD
Illyria Consulting Group, Inc., United States
President
The Grand Design: The Fundamental, Ongoing and Unrelenting Contribution of the Medical Monitor to the Drug Development Process
Stephen B. Shrewsbury, MD, FFPM
LifeSplice Pharma, Canada
Advisory Board
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