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DIA 2021 Global Annual Meeting
If You Have Questions, Contact the Regulatory Project Manager: Best Practices When Interacting with US FDA Regulatory Project Managers
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.
Deepika Jalota, PharmD
- Chief Regulatory and Quality Officer
- PMV Pharmaceuticals, United States
Rachael Steiner-Swiat, MBA, MSc
- Vice President, Global Regulatory Affairs, Oncology- Solid Tumors
- Novartis Pharmaceuticals Corporation, United States
Jacqueline Ware, PharmD
- Deputy Director, Office of Regulatory Operations, Office of New Drugs, CDER
- FDA, United States