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