Valeria Gigante, Ph.D.

Valeria Gigante, Ph.D.

World Health Organization (WHO)

Valeria Gigante, Ph.D., is a clinical pharmacologist and senior regulatory affairs specialist with 14 years of experience in public health and drug development. She serves as team lead in the AMR Division at the World Health Organization (WHO), where she coordinates research and priority-setting.

Before joining WHO in 2017, Gigante worked as a scientific officer for the European Medicines Agency (EMA) on the safety and efficacy of medicines for human use, for the Italian Medicines Agency (AIFA) as clinical assessor (PK/PD) for EU centralized procedures and scientific advice.

Gigante holds a master’s 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 executive education from INSEAD. She has published with the EMA Modelling and Simulation Working Group (MSWG) on advanced methods for dose and regimen finding during drug development and model-informed drug discovery and development (MID3) good practices and with WHO on bioequivalence/biowaiver, on AMR and on antimicrobials and vaccines R&D. She is currently writing and contributing to several WHO policy documents and publications.

Gigante 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. Currently, she represents WHO in the GARDP’s Scientific Advisory Committee, in the AMR Action Fund Scientific Advisory Board and in the Global AMR R&D Hub Board.