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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

Session Chair(s)

Todd  Paporello, PharmD, MBA

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.

Speaker(s)

Deepika  Jalota, PharmD

Industry Perspective

Deepika Jalota, PharmD

  • Chief Regulatory and Quality Officer
  • PMV Pharmaceuticals, United States
Rachael  Steiner-Swiat, MBA, MSc

Industry Perspective

Rachael Steiner-Swiat, MBA, MSc

  • Vice President, Global Regulatory Affairs, Oncology- Solid Tumors
  • Novartis Pharmaceuticals Corporation, United States
Jacqueline  Ware, PharmD

FDA Perspective

Jacqueline Ware, PharmD

  • Deputy Director, Office of Regulatory Operations, Office of New Drugs, CDER
  • FDA, United States