US Group Head Regulatory Medical Writing, Pharma, Novartis Pharmaceuticals Corporation
Mary Lynn Mercado is a US Group Head of Regulatory Medical Writing, Pharma at Novartis Pharmaceuticals Corporation. She has over 10 years of experience in the biopharmaceutical industry in Medical Writing, during which she has supported submissions across multiple therapeutic areas...
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Scientific Administrator, Compliance and Inspection, European Medicines Agency
Noémie Manent joined the European Medicines Agency EMA in March 2011 as a Principal Scientific Administrator in the Compliance and Inspection Sector. She is involved in the coordination of EMA Good Clinical Practice (GCP) and pharmacovigilance inspections. She also has a major role...
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Associate Directo, Biomedical Informatics & Regulatory Review Science, OND, CDER, FDA
Dr. Vaishali Popat is an Associate Director for Biomedical Informatics in the Office of New Drugs, Immediate Office. Dr. Popat is the OND lead on biomedical informatics issues in areas such as safety analytics, staff training on the use of new review tools to make the evaluation of...
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Medical Reviewer, Office of Advanced Evaluation with Electronic Data, Pharmaceuticals and Medical Devices Agency (PMDA)