Regulatory Specialist
Agência Nacional de Vigilância Sanitária (ANVISA)
Cássia de Paula Roesler Savino is a Regulatory Specialist at the Brazilian Health Regulatory Agency (ANVISA), with over 10 years of experience in the review of health-regulated products, regulatory frameworks, and standards. Since 2017, she has been engaged in the evaluation of biological licensing applications and post-marketing submissions, including biosimilar products, with a focus on assessing clinical data on safety and efficacy, as well as quality-related aspects, within the Biological Products Evaluation Office (GPBIO). She currently serves as Topic Leader for the ICH M18 Expert Working Group, contributing to the development of international guidelines for the evaluation of biosimilars. She holds a Bachelor’s degree in Biology from the University of Campinas (Unicamp) and has completed advanced training in clinical research and regulatory affairs at leading international institutions, including the Harvard T.H. Chan School of Public Health, the Pan American Health Organization (PAHO/WHO), and the National Institutes of Health (NIH).
Expanding Global Biosimilar Access: Converging Regulatory Approaches with Analytical Insights
Thursday, October 9, 2025
4:30 PM - 5:30 PM EST