FDA Presents: Ophthalmic Generic Drug Development and Approval: Challenges and Recent Research

Published on: 


Thursday, August 5, 2021 at 11am EDT| 8am PDT| 4pm BST|5pm CEST

Register Free: https://www.pharmtech.com/pt_w/ophthalmics

Key Learning Objectives:

  • Understand the regulatory framework for generic ophthalmic drug products
  • Hear about recent pharmacokinetic and pharmacodynamic studies to better understand the in-vivo impact of differences in product formulation
  • Learn about recent advances in the development of ocular physiological-based pharmacokinetic (PBPK) modeling and simulation

Who Should Attend:

  • Drug development scientists
  • Generic drug manufacturers


Darby Kozak
Deputy Division Director
US Food and Drug Administration, Office of Generic Drugs

Dr. Darby Kozak is the Deputy Division Director for the Division of Therapeutic Performance One (DTP1), Office of Research and Standards (ORS), Office of Generic Drugs (OGD). In this role, he leads a group of interdisciplinary scientists and oversees research projects on the development of new analytical methods and equivalence evaluation methodologies for complex drug products and formulations. He specializes in complex drug substances, products that incorporate nanotechnology, and complex parenteral, ophthalmic, and otic formulations. Prior to joining the FDA in 2015, Dr. Kozak was the chief scientist for Izon Science, a research fellow at the Australian Institute for Bioengineering and Nanotechnology, and visiting fellow at the Fred Hutchinson Cancer Research Center. Dr. Kozak has a bachelor’s degree in chemical engineering from the University of Washington (Seattle, WA) and a doctorate in chemistry from the University of Bristol (United Kingdom).

Register Free: https://www.pharmtech.com/pt_w/ophthalmics