Speaker: Dr Mary Mazur-Melnyk

Seminar will be conducted online via Zoom @ 5:30 pm EDT

Abstract

The presentation will provide an overview of the regulatory process and associated requirements during all phases of clinical study drug development conducted both in the US and Canada with the ultimate focus of market approval.  The main objective is to provide a basic understanding of all the interrelated elements that need to be successfully executed in the drug development process from a regulatory perspective.  Specifically, the various stages of clinical research; initiation of a clinical trial application its structure and contents and regional differences; overview of essential documents and applicable standards and principles. 

About Speaker

Mary Mazur-Melnyk has over 35 years of pharmaceutical and biologics experience specifically in the areas of product development, scale-up, quality management, product management and registration maintenance.  She has established and headed both quality and regulatory teams leading to many successful product registrations at Sanofi Pasteur, GlaxoWellcome, Novartis, Biomira, Biovail and most recently Ironshore Pharmaceuticals. She holds a Ph.D. in toxicology/molecular biology and a M.Sc. in Medical Sciences.