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Tuesday, June 25 • 2:00pm - 3:15pm
#269: Driving Complex Generics to Approval: What are the Keys to Success

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-620-L04-P; CME 1.25; IACET 1.25; RN 1.25

GDUFA II provides new regulatory processes designed to accelerate access to generic versions of complex products. In thisforum, FDA and industry provide examples on how to effectively use these processes.

Learning Objectives

Explain how the FDA review of ANDAs for complex generics has been improved under GDUFA II; Describe current regulatory and scientific considerations for generic combination products; Develop strategies to communicate more effectively with FDA during development of a complex product intended for submission under an ANDA.

Chair

Robert A. Lionberger, PhD

Speaker

Industry Perspective
Michelle Lee-Bourner, MSc

FDA Update
Martha Nguyen, JD



Speakers
avatar for Martha Nguyen

Martha Nguyen

Director, Division of Policy Development, OGD, CDER, FDA
Martha Nguyen is the Director of the Division of Policy Development in FDA CDER's Office of Generic Drugs, where she provides strategic leadership and direction on broad policy issues affecting generic drugs and oversees the development and clearance of regulations, guidance documents... Read More →
avatar for Michelle Lee-Bourner

Michelle Lee-Bourner

Head Global Respiratory and Biologics Regulatory Sciences, Mylan Pharma UK Ltd
Michelle Lee-Bourner has 30 years’ experience of drug pharmaceutical research and development, focused mainly on NCE’s and more recently generics, biosimilars and biologics. At Pfizer Michelle’s career spanned drug discovery, early clinical research and Regulatory Affairs. Michelle... Read More →
avatar for Robert Lionberger

Robert Lionberger

Director, Office of Research and Standards, Office of Generic Drugs, CDER, FDA
Robert Lionberger, Ph.D. serves as Director of the Office of Research and Standards (ORS) in the Office of Generic Drugs (OGD). Dr. Lionberger leads OGD’s implementation of the GDUFA science and research commitments including internal research activities and external research grants... Read More →


Tuesday June 25, 2019 2:00pm - 3:15pm
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA