Jose Crisostomo

Pharmacist with ten-year experience in the private pharmaceutical industry and the national regulatory agency of Chile (Chilean Public Health Institute (ISP)). Experience and growth in different areas, such as product research and development and manufacturing of different pharmaceutical forms for two years. 10 years working in different areas of the NRA of Chile, such as CMC, GMP, and regulatory affairs, focused on biological products and especially in vaccines. Strong knowledge in the development of pharmaceutical products, scale-up, process validation, GMP inspection, and CMC evaluation for generic and biological products. Specialization in reviewing the common technical document (CTD), mainly Module 3 for the marketing authorization process in the Chilean market for biopharmaceuticals, and reviewer of this module for WHO prequalified vaccines. During 2020 and 2021 dedicated to coordinating the evaluation of the quality, efficacy, and security of the COVID-19 vaccines that submitted documentation to be used in Chile. Furthermore, dedicated to the evaluation of the CMC for all the COVID-19 vaccines in Chile, comprising Pfizer, Sinovac, Covaxin, Sputnik, AstraZeneca, and Janssen, and the exchange of experience with other NRAs of the region and the world such as ANVISA, ANMAT, COFEPRIS, INVIMA, and EMA. During this period I was designated as the focal point of information for COVID-19 vaccines in Chile for the PAHO/WHO, participating in training, discussion, and informative meetings. Since 2023 member of the NITAG of Chile and head of marketing authorization for biological products at ISP Chile.