Agnes V. Klein MD, DPH, a graduate in Medicine and Public Health from the University of Toronto, is currently the Senior Medical Advisor in the Biologics and Genetic Therapies Directorate in Health Canada. Amongst Dr. Klein’s many interests the following may be noted: biomedical ethics, acting as an expert at ICH in the development of Genomics Guidelines and the appropriate design of clinical trials. Dr. Klein has over 40 years’ experience in various aspects of the development and regulation of therapeutics, including Pharmaceuticals and Biologics.
Over the years, Dr. Klein has received wide recognition and awards for her regulatory work voth from outside Health Canada and within the Department. To note are a DIA award, a Queen’s Jubilee Medal, a Deputy Minister’s recognition award and a CSPS Fellowship.
Dr. Klein has also made many presentations on regulatory/clinical/scientific matters and has written and contributed to a number of publications on drug development and clinical trials.