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Virtual

13 jun 2022 2:00 p.m. - 13 jun 2022 5:00 p.m.

(Eastern Standard Time)

Defining the Clinical Questions of Interest: Why Everyone Developing a Protocol Should Understand Estimands!

Instructors

Rekha  Jhamnani, MD, MSc

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

Khalid Puthawala, MD

Medical Officer, DPACC, OND, CDER , FDA, United States

Elisa  Gomez Valderas, MS

Elisa Gomez Valderas, MS

Senior Advisor, Eli Lilly and Company, United States

Munish  Mehra, PhD, MS, MSc

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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