Health Regulation Expert
Elkiane is a Health Regulation Expert at the Biological Products Office of the Brazilian Health Regulatory Agency – ANVISA. She has been working for 16 years as a reviewer of Anvisa, and the last 7 years reviewing both 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).