Speakers

Dr. Emilija Fredro-Kumbaradzi is Director of Biopharmaceutics and Statistics at Apotex. She is responsible for Biopharmaceutics aspects in the development of generic drug products. Her work spans dissolution science, in vitro comparisons, in silico modeling, and biowaiver justifications, ensuring alignment with global regulatory standards. She also oversees clinical research activities related to bioequivalence studies and clinical study design, with a focus on regulatory strategy and scientific integrity. With over 20 years at Apotex, Dr. Fredro-Kumbaradzi brings extensive experience in the biopharmaceutic evaluation of solid oral dosage forms. She holds a Ph.D. in Pharmaceutical Sciences from the University of Skopje, Macedonia, where she previously served as a Professor of Pharmaceutical Technology.