Speakers

Dr. Nilufer Tampal is the Associate Director for Scientific Quality in OB within OGD. In this role, Dr. Tampal develops strategies and oversees implementation of data quality and the scientific integrity of bioequivalence data submitted in Abbreviated New Drug Applications (ANDAs). She provides leadership and expertise in utilization of advanced analytic data tools in the assessment of bioequivalence studies submitted in ANDAs. Dr. Tampal serves as the FDA Topic Lead for the ICH Expert Working Group on M13: Bioequivalence for Immediate Release Solid Oral Dosage Forms. She also served as the Rapporteur for the ICH Generic Drug Discussion Group. Dr. Tampal received her Ph.D. in Toxicology from the University of Kentucky and an M.S. in Chemistry from Bombay University, India. She started her career at the FDA in 2002, as an investigator in the Office of Study Integrity and Surveillance and has held various leadership positions in OB for the last 12 years. Prior to her FDA career, she gained years of experience in synthesis and analysis of small molecules working as chemist at a multinational pharmaceutical company in India.