Valeria Gigante is a Clinical Pharmacologist and a senior Regulatory Affairs and Health Policy specialist with fourteen years of experience in public health. She is a Team Lead at the World Health Organization’s (WHO) AMR Division, where she coordinates research and priority-setting.
Valeria started her career in Regulatory Affairs in London at the European Medicines Agency (EMA) in 2007, where she worked as a Scientific Administrator on the safety and efficacy of medicines for human use. She joined the Italian Medicines Agency (AIFA) in 2010 as Clinical Assessor (PK/PD) for EU centralized procedure and Scientific Advice, then the WHO in 2017, where she coordinated the development of WHO guidelines on pharmaceutical regulation.
She has published with the EMA Modelling and Simulation Working Group (MSWG) on advanced methods for dose and regimen finding during development, model-informed drug discovery and development (MID3) good practices, scaling dose exposure-response and with WHO on Bioequivalence/Biowaiver, on AMR, and antimicrobials and vaccines R&D. She is currently writing and contributing to several WHO policy documents and publications. She collaborates as a peer reviewer with the WHO Bulletin.
Valeria has served as an expert on international expert groups such as the EMA MSWG and the Council of Europe Working Party on Pharmaceuticals and Medical Devices for the revision of Regulation N. 726/2004/EC. She currently represents WHO in GARDP’s Scientific Advisory Committee, on the AMR Action Fund Scientific Advisory Board and on the Global AMR R&D Hub Board.
Valeria holds a master’s degree in Pharmacy with training in Microbiology and Hygiene and a PhD in Pharmacology and Toxicology on available therapies for multidrug-resistant tuberculosis (MDR-TB).