Regulation Expert Witness |
Regulation | E-007728
Expert Qualifications
This expert has been working in regulatory affairs for nearly 25 years. As a Regulatory Affairs Associate with Bayer Healthcare Pharmaceuticals, he gained significant experience in all facets of drug life cycle, from coordinating, evaluating, and filing submissions for new and marketed products, to responding to Health Canada requests and negotiating with Health Canada scientific reviewers, to preparing and following clinical trial applications. He wrote and revised Product Monographs in consultation with medical and marketing departments, reviewed labeling and promotional material to ensure compliance, and conducted product label audits. He is a member and former Director of the Canadian Association of Professional Regulatory Affairs and also holds membership in the Regulatory Affairs Professional Society. Currently, this expert is the Principal of his own regulatory affairs consulting firm, providing regulatory expertise and services in the pharmaceutical, biotech, and medical device industries.
Bio Snapshot
Location: Quebec
B.Sc., University of Waterloo
M.Sc., McGill University
Member, Canadian Association of Professional Regulatory Affairs
Member, Regulatory Affairs Professional Society
Former, Research Technician, ICI Agrochemicals
Former, Regulatory Affairs Officer, Agriculture Canada
Former, Regulatory Affairs Associate, Nordic Merrell Dow Research
Former, Regulatory Affairs Associate, Bayer Healthcare Pharmaceuticals (Berlex Canada)
Current, Principal, regulatory affairs consultancy
