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CTD Regulatory Defense Strategies: How Best to Prepare Your Response to Health Authority Queries
Session Chair(s)
Frank Hubbard, PhD, MS
President
Global Regulatory Writing Solutions Inc., United States
Addressing questions posed to your company by a health authority during the review of your marketing application (ie, reg defense) is a critical and often overlooked part of the process leading to approval of your product. This session will equip the audience with authoring strategies that have worked well to develop robust and timely responses to Health Authority questions. Case studies will be used to demonstrate how these processes have been applied effectively on large response projects, and real-life examples of tools and processes that have been used to manage these activities will also be discussed.
Learning Objective : Develop a strategy that effectively plans and coordinates authoring teams to prepare responses in a timely manner; Discuss the pros and cons of resourcing for handling regulatory responses; Identify some of the key potential conflicts between regulatory defense and other ongoing activities; Demonstrate a plan for triaging and rapidly responding to regulatory defense queries.
Speaker(s)
Field Tested Strategies for How Best to Prepare Responses to Health Authority Questions
Julia Forjanic-Klapproth, PhD
Trilogy Writing & Consulting, Germany
Senior Partner/President
Finding the Right Balance of Preparation and Structure for Regulatory Defense
Steve Sibley, MS
Certara , United States
Vice President, Global Submissions and Submissions Leadership
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