Gustavo Mendes Lima Santos
Fellow, Regulatory Affairs
Gustavo Mendes Lima Santos is a Pharmacist with a master’s degree in Toxicology from the University of Londrina Brazil (2011).
Previously he was the General Manager of Medicines and Biological Products at the Brazilian Health Regulatory Agency (Anvisa). Gustavo has more than 19 years of experience as a regulator, acting in the Therapeutic Equivalence department evaluating studies, and inspecting CROs. He worked in implementing various regulatory instruments like clinical efficacy and safety guidelines for synthetic medicines and therapeutic equivalence of inhaled and nasal products.
He has participated in global regulatory harmonization initiatives, representing Anvisa in the International Council for Harmonisation as an expert in the M9 working group and on the Management Committee. During the COVID-19 pandemic, he worked as a regulator to implement strategies for establishing emergency use authorization of medicines and vaccines.
Since July 2022, Gustavo has been assigned as a Research Scientist in the Regulatory department of the International Vaccine Institute, a non-profit organization created by the United Nations Development Programme with the objective of developing vaccines for low and middle-income countries, with a focus on neglected diseases.