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Hyatt Regency Bethesda

Apr 13, 2015 7:00 AM - Apr 15, 2015 12:00 PM

One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814-5326

CMC Workshop 2015

Session 6C: Comparability Biologicals

Session Chair(s)

Anthony  Ridgway, PhD

Anthony Ridgway, PhD

Acting Director, Biologics and Genetic Therapies Directorate

Health Canada, Canada

Speaker(s)

Anthony S Lubiniecki

An Industrial View of Comparability Applied to Biopharmaceuticals

Anthony S Lubiniecki

Janssen R&D LLC, United States

Senior Scientific Director & Fellow

Linan  Ha

FDA Perspective

Linan Ha

FDA, United States

Team Leader, Division of Biotechnology Review & Research I, OBP, OPQ, CDER

Kowid  Ho, PharmD

European Perspective

Kowid Ho, PharmD

F. Hoffmann-La Roche Ltd, Switzerland

Pharma Technical Regulatory Policy

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