Jose Crisostomo

Pharmacist with ten-year experience in the national regulatory agency of Chile (Chilean Public Health Institute (ISP)) and private industry. Knowledge in different areas, such as pharmaceutical product manufacturing for two years, eight years of experience working in different areas of the NRA of Chile, like CMC, GMP, and regulatory affairs. Strong understanding 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, including vaccines, monoclonal antibodies, and biosimilars. During 2020 and 2021 dedicated exclusively 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. Designated responsible as the focal point of information for COVID-19 vaccines in Chile for the PAHO/WHO, participating in training, discussion, and informative meetings. Finally, since 2022 head of the department for marketing authorization for biological products in ISP Chile.