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Tuesday, June 26 • 4:15pm - 5:30pm
#290: Priority Review Vouchers: Here to Stay and Worth the Effort?

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Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-566-L04-P; CME 1.25; IACET 1.25; RN 1.25

Priority review vouchers (PRV) have been around since 2007, and the opportunities to earn one have expanded. This session will discuss the value of a PRV, FDA process for awarding them, and things to consider when developing a regulatory strategy.

Learning Objectives

Assess the value of a priority review voucher; Evaluate whether a priority review voucher should be incorporated into your development program; Discuss a plan for FDA evaluation of your priority review voucher request.

Chair

Kim Quaintance-Lunn

Speaker

Value
Andrew Robertson, JD, PhD

Strategy
John Jenkins

Process
Larry Bauer, MA, RN



Speakers
avatar for Larry Bauer

Larry Bauer

Regulatory Scientist, Rare Diseases Program, Office of New Drugs, CDER, FDA
Larry Bauer is a Regulatory Scientist in the Center for Drug Evaluation and Research, Office of New Drugs Immediate Office (CDER, OND IO) in the Rare Diseases Program. He provides regulatory expertise internally and externally regarding FDA laws, regulations, guidances and policies... Read More →
JJ

John Jenkins

Principal, Drug and Biological Products, Greenleaf Health
Dr. John Jenkins is Principal, Drug and Biological Products at Greenleaf Health. Prior to joining Greeleaf, Dr. Jenkins was Director of the Office of New Drugs at FDA’s Center for Drug Evaluation and Research from 2002 to 2017. Dr. Jenkins received his M.D. degree from the University... Read More →
avatar for Kim Quaintance-Lunn

Kim Quaintance-Lunn

Vice President and Head, Regulatory Policy, North American Regulatory Affairs, Bayer
Kim Quaintance-Lunn serves as Vice President and Head, Regulatory Policy, North American Regulatory Affairs, at Bayer. Kim joined Bayer in February 2014 to establish and lead the US regulatory policy function for the organization. She works with colleagues to analyze regulatory policy... Read More →
AR

Andrew Robertson

Head, Global Regulatory Science and Policy, NA, Sanofi
Andrew Robertson is the Head of Regulatory Science and Policy NA at Sanofi, where he heads up regulatory policy initiatives in the US and Canada. Andrew has more than 14 years of collective experience working in life sciences, policy and law, and has authored multiple peer-reviewed... Read More →


Tuesday June 26, 2018 4:15pm - 5:30pm
Room 206AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA