Director
US Food and Drug Administration
Clarksburg
Dr. Tahseen Mirza is an accomplished scientist and leader with over twenty-five years of industrial and regulatory experience in the areas of generic and branded pharmaceutical and device development. He holds a Ph.D. in Pharmaceutical Sciences from University of Cincinnati.
In his current job, Dr. Mirza is Associate Director for Regulatory Affairs in FDA/CDER Office of Study Integrity and Surveillance. Prior to joining the FDA, he worked in various pharmaceutical companies and The United States Pharmacopeia where he led groups of chemists and Ph.D. level scientists in various R&D and QC/QA departments. Most recently, he was a Director in the Technical R&D department of Novartis Pharmaceutical Corp, East Hanover, NJ. Dr. Mirza is well versed in both early and late phase drug development.
He has moderated national and international conference/workshops on variety of topics such as drug release, dissolution, QbD and PAT. He has published in peer-reviewed journals and co-authored book chapter.
Dr. Mirza is the founding Chairman of the AAPS focus group, In Vitro Release and Dissolution.
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In vitro Bioequivalence - Trends in Regulatory Review and Inspections
Monday, November 10, 2025
9:30 AM - 10:00 AM CT