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Thursday, June 17 • 12:00pm - 1:00pm
#510 OD: If You Have Questions, Contact the Regulatory Project Manager: Best Practices When Interacting with US FDA Regulatory Project Managers

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Component Type: Session
Level: Basic

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 Objectives

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.

Chair

Todd Paporello, PharmD, MBA

Speaker

Industry Perspective
Deepika Jalota, PharmD

Industry Perspective
Rachael Steiner-Swiat, MBA, MSc

FDA Perspective
Jacqueline Ware, PharmD



Speakers
avatar for Deepika Jalota

Deepika Jalota

Chief Regulatory and Quality Officer, PMV Pharmaceuticals, United States
Dr. Jalota is Chief Regulatory and Quality Officer at PMV Pharma, a precision oncology company. Prior to joining PMV Pharma, Dr. Jalota was Vice President, Global Regulatory Strategy, Oncology I at Bayer where she was responsible for overseeing the development of global regulatory... Read More →
avatar for Rachael Steiner-Swiat

Rachael Steiner-Swiat

Vice President, Global Regulatory Affairs, Oncology- Solid Tumors, Novartis Pharmaceuticals Corporation, United States
Rachael Steiner-Swiat is a global regulatory affairs leader with over 20 years experience. She is responsible for leading and managing employees to develop the global regulatory strategy for a broad portfolio of approved and investigational biologics and drugs across oncology, respiratory... Read More →
avatar for Todd Paporello

Todd Paporello

Vice President and Head of Regulatory Affairs Americas, Bayer, United States
Todd Paporello is Vice President and Head of Regulatory Affairs Americas at Bayer Pharmaceuticals. Before joining Bayer, he held leadership positions of increasing responsibility within regulatory affairs at Roche, Genentech, Merck, and Schering-Plough. Todd holds pharmacy (PharmD... Read More →
avatar for Jacqueline Ware

Jacqueline Ware

Deputy Director, Office of Regulatory Operations, Office of New Drugs, CDER, FDA, United States
Jacqueline Ware, PharmD, is the Deputy Director of the newly formed Office of Regulatory Operations (ORO) in CDER’s Office of New Drugs (OND). In partnership with ORO’s Director, she is responsible for oversight of OND’s regulatory review processes and regulatory project management... Read More →


Thursday June 17, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session |   20: Early Access Content, Session