July 09 2025 CAPRA Montreal Dinner Meeting

ABOUT OUR GUEST

Andy Hua has over 20 years of experience at Health Canada, serving in a variety of regulatory and policy roles. Throughout his career, he has worked across several offices within the Pharmaceutical Drugs Directorate, including project managing drug submissions and serving as an Associate Director in a drug review bureau. A key highlight of Andy’s career has been his work in international affairs, where he collaborated with global regulatory partners to advance joint reviews in drug submissions. Most recently, as the policy lead for the Product Monograph Working Group, Andy led the development and publication of an updated Product Monograph Guidance and Master Template—an initiative shaped through consultation with both internal and external stakeholders.

ABOUT OUR GUEST

Tracy Brown as worked at Health Canada in the regulatory environment for over 25 years. She started her career at the Pest Management Regulatory Agency before joining the Health Products and Food Branch, where she has worked for most of her career. Tracy has worked in regulatory roles in both the Biologic and Radiopharmaceutical Drugs Directorate and the Pharmaceutical Drug Directorate. She participated in many regulatory projects and led the guidance document revisions for related to the CTD and eCTD formats. Tracy is currently a Senior Project Manager within the Business Facilitation and Modernization Directorate’s Business Informatics Division, where she has successfully led several major projects. Tracy assumed the lead of the XML PM project in 2020.