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Responding to Regulatory Questions and Feedback
Session Chair(s)
Noah Gourlie, MS, MSc
Associate Director, Medical Writing
Veristat Inc, United States
The session will provide an overview of the general principles behind preparing for regulatory questions after the submission of an application for regulatory approval (e.g., NDA or MAA), especially identifying steps that can be taken in advance of receiving the questions. The specific case and requirements of revising a Pediatric Investigation Plan after EMA Pediatric Committee application review will be examined in detail. Finally, best practices for managing the process of developing the responses will be discussed.
Learning Objective : At the conclusion of this session, participants should be able to: - Create a plan to address regulatory questions to support a submission (e.g., NDA/MAA) - Create a package for submission based on revisions to Pediatric Investigation Plan as a result of EMA Pediatric Committee application review - Describe best practices for managing the authoring and review of responses to regulatory questions
Speaker(s)
Faculty
Tracy Lovejoy, PharmD
NO NOT MERGE THIS PROFILE, United States
Faculty
Renee Primus, PhD, MSc
Bristol-Myers Squibb Company, United States
Head, Regulatory Documentation Scientific Writing, Full Development and Safety S
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