Dr. Valeria Gigante is a Clinical Pharmacologist and a senior Regulatory Affairs and Health Policy specialist with thirteen years’ experience in public health. She is Team Lead at the World Health Organization (WHO) in the AMR Division where she coordinates research and priority-setting.
Dr Gigante started her career in Regulatory Affairs in London at the European Medicines Agency (EMA) in 2007 where she worked as Scientific Administrator on 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. She joined the WHO in 2017 where she coordinated the development of WHO guidelines on pharmaceutical regulation.
Dr Gigante holds a Master Degree in Pharmacy with training in Microbiology and Hygiene and a Ph.D. in Pharmacology and Toxicology on available therapies for MDR-TB.
She has published with the EMA MSWG on advanced methods for dose and regimen finding during development, on MID3 good practices, on scaling dose exposure response and with WHO on Bioequivalence/Biowaiver. She is currently writing and contributing to several WHO guidelines, policy documents and publications. She contributes as peer reviewer to the WHO Bulletin.
Dr Gigante has served as an expert on international experts groups such as the EMA Modeling and Simulation Working Group (MSWG) and the Council of Europe Working Party on Pharmaceuticals and medical devices for the the revision of the Regulation N. 726/2004/EC. She represents WHO at the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).