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Wednesday, June 26 • 2:00pm - 3:15pm
#369: User-Fee Programs Myth Busting: General Financial Principles Explained

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Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-693-L04-P; CME 1.25; IACET 1.25; RN 1.25

With preliminary user-fee reauthorization discussions underway, it is important to refresh on the financial principles behind a user-fee program and hear an update on the PDUFA VI, GDUFA II, and BSUFA II resource management commitments. Don't miss this fantastic educational opportunity to learn more about FDA's financial management.

Learning Objectives

Explain how the FDA financials operate beyond the collection of user-fees; Describe and name the general financial principles behind a user-fee program; Describe how FDA utilizes its resources, and discuss the restrictions FDA is under being part of the federal government; Summarize FDA’s progress in implementing the PDUFA VI, GDUFA II, and BSUFA II resource management related commitments.

Chair

Amy Bertha

Speaker

Panelist
James Tyler

Panelist
Andrew Kish, MS


Speakers
avatar for Amy Bertha

Amy Bertha

Executive Director, Regulatory Policy and Innovation, Bayer, United States
Amy Bertha is currently Executive Director, Regulatory Policy and Innovation at Bayer. Her prior experience includes, regulatory program and project management at FDA Center for Drugs and Evaluation, regulatory affairs at Pfizer, and research scientist at Hoffman-La Roche. She is... Read More →
avatar for Andrew Kish

Andrew Kish

Director, Office of Program and Strategic Analysis, OSP, CDER, FDA, United States
Andrew is the Director of the Office of Strategic Programs and Analysis (OPSA) in the Center for Drug Evaluation and Research (CDER) in the U.S. Food and Drug Administration (FDA). Andrew oversees projects that span the application of economics, program evaluation, decision science... Read More →
avatar for James Tyler

James Tyler

Chief Financial Officer, Office of Operations, OC, FDA
Jay Tyler has 31 years of federal financial management experience serving at multiple federal agencies with diverse missions having broad national and international impact. He joined the U.S. Food and Drug Administration (FDA) in October of 2012 as the Chief Financial Officer (CFO... Read More →

Wednesday June 26, 2019 2:00pm - 3:15pm PDT
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Session