Kamali Chance
Quintiles, Inc, USA
Biography
Dr. Kamali Chance is a Vice President and Head, Global Biosimilars Regulatory Strategy, Biosimilars Center of Excellence. She has over 25 years of work experience in the healthcare industry, including the last 17 years in regulatory affairs/regulatory strategy. Dr. Chance has extensive experience working with the FDA and EMA. She advises pharmaceutical and biotechnology companies in the development of region specific and/or global regulatory strategy for the development of biosimilar products. Dr. Chance has authored/co-authored number of articles on the development of biosimilars. She has a PhD in Nutrition/Nutritional Biochemistry, Masters of Public Health and Regulatory Affairs Certification.
Abstract
Abstract : FDA/EMA Current thinking on totality of evidence for biosimilar approvals