Menu Back toIf You Have Questions, Contact the Regulatory Project Manager: Best Practices When Interacting with US FDA Regulatory Project Managers
Don't Miss Out!
Get your weekly Breakfast Briefing eNewsletter, filled with news, trends, and vital information from DIA!
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 and Head of Regulatory Affairs Americas
- Bayer, 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