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Session 7: Assuring Data Integrity in Drug Applications: Regulatory Expectation, Challenges and Case Study
Session Chair(s)
Aditi S Thakur
Senior Pharmaceutical Assessor, Office of Pharmaceutical Manufacturing Assessmen
t, Office of Pharmaceutical Quality, CDER, FDA, United States
Utpal Munshi, PHD
Division Director, Division of Bioequivalence I (DBI), Office of Bioequivalence,
Office of Generic Drugs, CDER, FDA, United States