After obtaining his Chemistry degree from Acadia University in Nova Scotia, Gary Condran was employed for several years in the Regulatory Affairs Departments of two multi-national generic companies in the Toronto area. Gary joined Health Canada in 1995 and has since held several positions across the Department and is currently the Manager of the Quality Risk Management and Operations Division within BPS. He has been HC’s rep. on several ICH working groups including the QDG, Q1, Q3A&Q3B and was the Regulatory Chair for the Q11 Q&A document. Gary coordinates actions and responses to Quality risk and drug shortage issues, including those associated with nitrosamines and is Co-Chair of the Nitrosamines International Technical Working Group.

Alison Ingham obtained her B.Sc. (Chemistry and Biochemistry) at the University of the Witwatersrand in South Africa and her Ph.D. in Chemistry from the University of Victoria. She joined Health Canada and within the Therapeutic Products Directorate, she has worked in areas assessing Generic and New Drugs. Alison has been involved since 2004 with the Certification process at the European Directorate for the Quality of Medicines and Health Care, and was appointed as an external assessor by EDQM in 2006. She held the position of Manager of Product Assessment at the Natural Health Products Directorate for 5 years before returning to the Bureau of Pharmaceutical Sciences to her current position of Senior Advisor/Manager.

Celia Lourenco, PhD has been the Director General of the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) of the Health Products and Food Branch of Health Canada since November 2018. She was previously the Senior Executive Director of the Therapeutic Products Directorate (TPD) and held other management positions within TPD over a period of about 10 years. In her various management roles, Celia has been responsible for the review and authorization of a variety of new drugs for human use, either for clinical trials or for market authorization in Canada. Celia has contributed to international initiatives such as ICH and IPRP, she co-chairs the ICMRA COVID-19 working group and participates on DIA's Council of Regulators.

Stephen McCaul is a Regional Regulatory Compliance and Enforcement Supervisor Supervisor, Drug inspection, Central Region, RAPB, Health Canada. Steve has held a number of positions within Health Canada over the past 27 years, including GMP inspector, MRA evaluator and most recently as a drug GMP supervisor based in Toronto. His team conducts inspections within and outside of Canada. Steve has a degree in Chemistry from the University of Toronto.

Sonia Myers joined Health Canada in 2000. She has held positions in the areas of clinical trials quality, international policy, and currently works in the New Drugs Quality Division, in the Bureau of Pharmaceutical Sciences. Prior to joining Health Canada, she worked as a quality control laboratory technician at a local biotechnology company, Iogen Corporation.

Mr. Nick Orphanos is a senior policy analyst with Health Canada, specializing in international affairs for drug regulation. Mr. Orphanos graduated from the University of Carleton in 2003 with a bachelor’s degree in Economics and joined Health Canada shortly after. Mr. Orphanos plays a key role in Health Canada’s membership at ICH as the ICH Coordinator while participating in the ICH Assembly and Management Committee activities. Mr. Orphanos currently also acts as the Secretariat for the International Pharmaceutical Regulators Forum (IPRF) and is also involved in Health Canada’s participation in the ACSS (Australia-Canada-Singapore-Switzerland) Consortium.

Amirthini Rajkumar, Ph.D received her doctorate in Chemistry from North Dakota State University, USA and worked as a Post-doctoral Research Fellow at University of Manitoba. Prior to joining Health Canada she worked as a Research Associate at Carleton University and as a Hazardous Material Specialist at the Department of National Defense. Since joining Health Canada she has held various positions and has represented Health Canada in the international collaborative activities with WHO, EDQM and served as an expert in the ICH Q11 Question and Answers. She has more than 15 years of experience in reviewing drug submission.

Krishnan has BPharm and MPharm degrees from India and a Ph. D. in Biopharmaceutics from Dalhousie University, Canada. He served AstraZeneca and Patheon, in R&D and Manufacturing divisions for six years, and as a tenured Associate Professor, School of Pharmacy, Memorial University of Newfoundland, Canada, for seven years. For the past seventeen years Krishnan has been serving Health Canada in various capacities including Manager of the New Drugs and Generic Quality divisions. He is presently serving the Bureau of Pharmaceutical Sciences as a Senior Scientific Advisor where he is involved in addressing various scientific issues including post-approval changes, Health Hazard Assessments and market shortages of drug products.

Alisa Vespa is a senior drug evaluator for the Risk Management Division at Health Canada and has been involved in Health Canada's response to the risk of presence of nitrosamine impurities in pharmaceutical products. Alisa is co-leading the Nitrosamine International Technical Working Group (safety sub-team), a consortium of global regulators that share information on technical issues and approaches to (for example) establish Acceptable Intake limits for nitrosamine impurities. Alisa is also an active participant in the Health and Environmental Sciences Institute (HESI) sub-teams that are working to address data gaps and improve risk assessments for nitrosamines.