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Bethesda North Marriott Hotel and Conference Center

Apr 08, 2019 1:00 PM - Apr 10, 2019 4:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

DIA/FDA Biostatistics Industry and Regulator Forum

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Session 5: Innovative Methods for Assessment of Complex Generic Products

Session Chair(s)

Jingyu (Julia) Luan, PhD

Jingyu (Julia) Luan, PhD

Executive Regulatory Science Director, BioPharmaceuticals R&D

AstraZeneca, United States

Cristiana Mayer, DrSc, PhD

Cristiana Mayer, DrSc, PhD

Head of Biostatistics

Johnson & Johnson Vision, United States

As defined in the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022 (Generic Drug User Fee Amendments II Goals or Commitment Letter), complex products generally include products with complex active ingredients, complex formulations, complex routes of delivery or complex dosage forms, complex drug-device combination products, and other products where complexity or uncertainty concerning the approval pathway or other alternative approach would benefit from early scientific engagement. In this session, speakers from FDA, industry, and academia will discuss the unique challenges in the assessment in complex generics from statistical, clinical, and regulatory perspectives.

Learning Objective : At the conclusion of this session, participants should be able to:
Define complex generics
Describe GDUFA II enhancements for complex generics
Understand the unique challenges in the assessment in complex generics from statistical, clinical, and regulatory perspectives

Speaker(s)

Robert A. Lionberger, PhD

Innovative Approaches for Complex Generics

Robert A. Lionberger, PhD

FDA, United States

Director, Office of Research and Standards, Office of Generic Drugs, CDER

Sarfaraz Niazi, PhD

Meaning of Complexity of Generics

Sarfaraz Niazi, PhD

University of Illinois, United States

Adjunct Professor of Biopharmaceutical Sciences

Stella C. Grosser, PhD, MS

The Bioequivalence of Complex Generic Drug Products

Stella C. Grosser, PhD, MS

FDA, United States

Division Director, Office of Biostatistics, OTS, CDER

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