Our senior consultants have extensive backgrounds and many years of experience working with Health Canada, the FDA and other regulatory agencies on regulatory, clinical and quality matters.
Anne Tomalin, BA, B.Sc., President
Previously from Searle, and founder of CanReg Inc., has over 25 years of experience in Regulatory Affairs specializing in Strategic Regulatory advice and consulting. Anne has participated in the Regulatory Initiatives Advisory Committee for the Pharmaceutical Manufacturers Association of Canada (PMAC). She has also served on the executive of the Pharmaceutical Sciences Group (PSG) and the Canadian Association of Pharmaceutical Regulatory Affairs (CAPRA). Anne has also been engaged as an instructor at Humber College in the Postgraduate Certificate Course focusing on Regulatory Affairs since 2001 when the course started. In Canada, Anne has also chaired the Manitoba, Saskatchewan and Ontario Committees for the Pharmaceutical Manufacturers Association of Canada (PMAC), now Rx&D, and she has worked with the Nova Scotia Department of Health to revamp their drug formulary. Anne is also engaged in teaching several regulatory courses to industry, including in-house training courses for several large companies. Anne has published articles and presentations on all aspects of Regulatory Affairs. She is a member of Canadian Associate of Professionals in Regulatory Affairs (CAPRA). Anne has Regulatory Affairs Certification (RAC) in Canadian, US and EU Regulatory Affairs.
John Wong, M.Sc.Pharm., Executive Director, Regulatory Drug Advertising & Promotion
John Wong is a bilingual pharmacist graduate from Université Laval. He started his career at the Toronto General Hospital as a Clinical Pharmacist in Oncology and Nutrition Support and later owned and managed a community pharmacy. In 1998, he joined the Pharmaceutical Advertising Advisory Board (PAAB), the national regulatory body for prescription drug advertising, and became the Deputy Commissioner / Chief Review Officer in 2001. After 10 years at PAAB, John decided to cross over to the ‘other side' and worked at Ogilvy CommonHealth as an Account Director where he helped launch specialty products into the Canadian market in Oncology, Urology, Hematology, HIV and Immunology (vaccines). John has a unique background from both the regulatory and marketing sides of drug advertising and an excellent understanding of the various advertising Codes, Policies and Guidelines.
Doreen Steen, Executive Director, Quality Assurance
Doreen has joined TPIreg, effective today, as Executive Director, Quality Assurance. Doreen is known to many of you. She has spent approximately 10 years consulting in the QA area at CanReg/Optum. Before joining Optum, Doreen worked in the pharmaceutical industry working in the consumer product line in a QA capacity.
Mary Speagle is Vice-President of Regulatory and Scientific Affairs at Therapeutic Products Inc. where she heads up a consulting team specializing in US and Canadian Regulatory Affairs. Mary's broad experience covering 20 years in regulatory consulting includes both prescription and OTC drugs (Pharmaceuticals, Biologics, Natural Health Products), Medical Devices and Cosmetics. Mary has been working in the consulting area since 1998. Prior to joining Therapeutic Products Inc., she headed up a consulting team at Mapi Life Sciences (previously OptumInsight and CanReg Inc.). She is a prior contributing author to the RAPS Fundamentals of Canadian Regulatory Affairs and has served on the CAPRA Board of Directors from 2009-2015 in various roles (Chair, Programming Committee Lead, Dinner Meeting Committee Lead and Student Relations Committee Lead). In addition to her activities on the Board of Regulatory Focus Mary is also a volunteer on the CAPRA Advisory Board and Programming Committee and is an active member of numerous other industry associations. Mary has a BSc. in Human Genetics from McGill University and spent more than 10 years in the research environment prior to transitioning to the regulatory area.