返回 Agenda
Session Chair(s)
Noah Gourlie, MS, MSC
Associate Director, Medical Writing
Veristat Inc, United States
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