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Tuesday, June 26 • 2:00pm - 3:15pm
#256: CTD Regulatory Defense Strategies: How Best to Prepare Your Response to Health Authority Queries

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-18-592-L04-P; CME 1.25; IACET 1.25; RN 1.25

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 Objectives

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.


Frank Hubbard, PhD


Field Tested Strategies for How Best to Prepare Responses to Health Authority Questions
Julia Forjanic Klapproth, PhD

Finding the Right Balance of Preparation and Structure for Regulatory Defense
Steve Sibley, MS

avatar for Julia Forjanic-Klapproth

Julia Forjanic-Klapproth

Senior Partner/President, Trilogy Writing & Consulting, Germany
After receiving her PhD in Developmental Neurobiology, Julia became a medical writer in 1997. In 2002, she co-founded Trilogy Writing & Consulting, a company specialized in medical writing of regulatory documentation. She is now Senior Partner and CEO, and continues to bring her enthusiasm... Read More →
avatar for Frank Hubbard

Frank Hubbard

President, Global Regulatory Writing Solutions Inc., United States
Following a 14-year career in the Medical Communications Science group at AstraZeneca, Frank founded Global Regulatory Writing Solutions Inc. in late 2013. GRW Solutions provides regulatory submission advice and Communications best practice to the pharmaceutical industry. From 2015... Read More →
avatar for Steve Sibley

Steve Sibley

Vice President, Global Submissions and Submission Leadership, Certara Synchrogenix, United States
With a career spanning more than 30 years in the pharmaceutical industry, Mr. Sibley has extensive experience across regulatory writing, consulting, and regulatory project leadership roles. He has successfully supported projects from discovery through approval and life cycle management... Read More →

Tuesday June 26, 2018 2:00pm - 3:15pm EDT
Room 210C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  04: MedAffairs-SciComm, Session