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If You Have Questions, Contact the Regulatory Project Manager: Best Practices When Interacting with US FDA Regulatory Project Managers
Session Chair(s)
Todd Paporello, PharmD, MBA
Vice President, Global Head of Regulatory Affairs, Specialty Care
Sanofi, United States
A panel of FDA and industry representatives will share best practices when forming a relationship with the FDA regulatory project managers including recommendations on how to work together to support timely and consistent interactions during the drug development process.
Learning Objective : Identify best practices when developing a strategy to support effective and consistent interactions between the sponsor and FDA Regulatory Project Manager during the drug development lifecycle; Describe opportunities to enhance FDA-sponsor interactions including the use of digital technology; Discuss FDA actions to date based on third-party assessments, public meetings, and industry feedback.
Speaker(s)
Industry Perspective
Deepika Jalota, PharmD
PMV Pharmaceuticals, United States
Chief Regulatory and Quality Officer
Industry Perspective
Rachael Steiner-Swiat, MBA, MSc
Novartis Pharmaceuticals Corporation, United States
Vice President, Global Regulatory Affairs, Oncology- Solid Tumors
FDA Perspective
Jacqueline Ware, PharmD
FDA, United States
Deputy Director, Office of Regulatory Operations, Office of New Drugs, CDER