Dr. Katherine Soltys, MD

Dr. Soltys is the Director of the Office of Clinical Trials in the Pharmaceutical Drugs Directorate of the Health Products and Food Branch, at Health Canada. In this role, she oversees all activities related to the approval and pharmacovigilance of clinical trials involving pharmaceuticals in Canada, as well as Health Canada’s Special Access Program. She also represents Health Canada internationally as a member of ICH and the ACCESS Consortium.
Before joining the Office of Clinical Trials in 2022, Dr. Soltys served as Director, Marketed Pharmaceuticals Bureau where she was responsible for the post-market surveillance of prescription pharmaceuticals in Canada. Prior to that, Dr. Soltys served as an Oncology Medical Evaluator, and then Manager, in the pre-market Oncology Pharmaceutical Review Division of Health Canada. In this role, Dr. Soltys represented Health Canada on several international regulatory initiatives regarding Patient Reported Outcomes, including the SISAQOL Consortium (Setting International Standards for the Assessment of Quality of Life data), led by the EORTC (European Organization for the Research and Treatment of Cancer). Dr. Soltys has also co-authored several peer-reviewed publications in this area.
Dr. Soltys received her MD degree and completed her post-graduate training at the University of Saskatchewan. She also completed a Post Graduate Certificate in Pharmacoepidemiology and Pharmacovigilance at the London School of Hygiene and Tropical Medicine. In addition to her regulatory work, Dr. Soltys maintains part time clinical practice at The Ottawa Hospital Cancer Centre, with a focus on the care of patients with lung cancer and gastrointestinal cancer.