Instructors
Rekha Jhamnani, MD, MSc
Medical Officer, DNPDI, OND, CDER, FDA, United States
Rekha Jhamnani is a medical officer in the Division of Nonprescription Drugs at the FDA. She completed medical school at the George Washington University School of Medicine and internal medicine residency at Georgetown University Hospital. She then completed a fellowship in Allergy Immunology at the National Institutes of Health.
Khalid Puthawala, MD
Medical Officer, DPACC, OND, CDER , FDA, United States
Elisa Gomez Valderas, MS
Senior Advisor, Eli Lilly and Company, United States
Munish Mehra, PhD, MS, MSc
Managing Director and Sr. Principal Biostatistician, Quantum Biopharma, United States
Munish Mehra serves as Executive Director and Principal Biostatistician at Tigermed US and as Managing Director at Tigermed, India Pvt. Ltd. During a career spanning 33 years, he gained extensive experience in the design, analysis and reporting of phase I-IV clinical trials across multiple therapeutic areas. He has represented sponsors at FDA Type B pre-IND, end of phase II and pre-NDA as well as Type C meetings as an expert biostatistician. Dr. Mehra is currently Chair of the DIA Statistics and Data Sc. Community and has chaired sessions at several DIA Annual Meetings. He holds a PhD in biostatistics and a MS in computer science from the Univ. of KY, as well as a MS in mathematics from the Indian Institute of Technology.
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