Elkiane is a Health Regulation Expert at the Biological Products Office of the Brazilian Health Regulatory Agency - ANVISA. She has been working for 18 years as a reviewer/assistant of Anvisa, and the last 8 years on activities involving the assessments of CMC and clinical trials dossiers of biological and biotechnological products, including biosimilars. She has been a member of ICH Q12 Expert Working Group. She holds a Pharmacy and Biochemistry Degree with specialty in Pharmaceutical Industry (2004), a Master’s degree in Toxicology (2013), a Postgraduate certificate in Toxicology (2009), and a Postgraduate certificate in Health Regulation (2007). Since 2022, she is also the Deputy Head of the Biological Products Office of ANVISA and coordinates the Online Optimized Assessment Project for post approval changes (PACs) applications, which is an innovative approach to accelerate the reviews, based on reliance pathways, online meetings and other optimized assessment tools, facilitating the access of treatments to patients.