戻る Agenda
Finessing Scientifically Accurate, Comprehensible, Compliant, Clinically-focused Module 2 Summaries of an eCTD-based Submission
Session Chair(s)
Nancy Katz, PHD
President
Illyria Consulting Group, Inc., United States
This forum features three speakers who will provide expert and proven strategies that enable scientifically accurate, on time, on budget eCTD-based submissions.
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