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DIA 2018 Global Annual Meeting

The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.

CTD Regulatory Defense Strategies: How Best to Prepare Your Response to Health Authority Queries

    Session Chair(s)
      Frank  Hubbard, PhD

      Frank Hubbard, PhD

      • 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 : This presentation will help participants understand the challenges of responding to numerous questions in parallel, identify what steps can be taken to effectively plan in advance and coordinate authoring teams to prepare responses in a timely manner, and recognize the importance of a systematic approach to ensure all questions are addressed.
      Julia  Forjanic Klapproth, PhD

      Field Tested Strategies for How Best to Prepare Responses to Health Authority Questions

      Julia Forjanic Klapproth, PhD

      • President
      • Trilogy Writing & Consulting, Germany
      Steve  Sibley, MS

      Finding the Right Balance of Preparation and Structure for Regulatory Defense

      Steve Sibley, MS

      • Vice President, Global Submissions and Submissions Leadership
      • Synchrogenix, a Certara Company, United States