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Tuesday, June 20 • 12:45pm - 1:45pm
#237: Strategies for Communicating with FDA

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Component Type: Session
Level: Intermediate

Do you ever wonder how your peers manage their interactions with FDA?  Do you wonder why your peers get a response when you do not?  What challenges, and what successes, have you had?  Join us for an interactive session to discuss best practices and strategies for communicating with FDA.  You will work in groups to evaluate a communication scenario, develop a set of options for your approach to communicating, and develop strategies, best practices, tips, etc. based on your experience and general knowledge.  This is not an overview of meeting types or timelines; this is an opportunity to brainstorm ideas and share strategic best practices around communication.

Learning Objectives

Explore various strategies for communication with FDA; Discover best practices for communication from your peers.

Chair

Leah Christl, PhD

Speaker

Session Co-Chair
Kim M. Quaintance-Lunn


Speakers
avatar for Leah Christl

Leah Christl

Associate Director for Therapeutic Biologics, TBBT, OND, CDER, U.S. Food and Drug Administration (FDA)
Dr. Christl is the Director of the Therapeutic Biologics and Biosimilars Staff (TBBS) in the Office of New Drugs in the FDA's CDER. TBBS is responsible for ensuring consistency in the scientific and regulatory approach and advice to sponsors regarding development programs for biosimilar... Read More →
avatar for Kim Quaintance-Lunn

Kim Quaintance-Lunn

Vice President, Regulatory Policy, NA, Bayer
Kim Quaintance-Lunn serves as the Vice President and Head, NA Regulatory Policy at Bayer. She works with colleagues to analyze regulatory policy and advocate for changes in the regulatory environment, serves on global and US Regulatory Leadership teams, and assists in the development... Read More →

Tuesday June 20, 2017 12:45pm - 1:45pm
Exhibit Hall McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  15:Engage-Exchange, Session