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., Executive Director
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.
Mary Speagle, Senior Director, Regulatory Affairs
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.
Justin Evans, Director, Regulatory Operations
Justin joined TPIreg in 2014. In his current role as head of the Regulatory Operations department, he is accountable for all electronic submissions (eCTD, NeeS, NNHPD etc) on behalf of clients, key management representation for a number of projects, and is an active member of the Senior Management team. Justin formed the TPIreg Regulatory Operations department in 2014, and also previously headed up the TPIreg CMC department. With over 20 years of experience in the pharmaceutical industry, he has also held various regulatory and quality assurance roles for pharmaceutical manufacturers in Canada and the UK. Justin has a B.Sc. Hons. Chemistry and M.Sc. Chemistry from Loughborough University, UK.
John K. Wong, M.Sc.Pharm, 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 Clark Steen, MA, Dip. (BChem), RAC, Senior Director, Quality Assurance
Doreen Clark Steen has more than 30 years of pharmaceutical industry experience, including positions in both Quality Assurance and Regulatory Affairs at OPTUMInsight Canada, GSK, GSK Consumer Healthcare, Johnson & Johnson (McNeil Consumer Products), and Procter & Gamble (Richardson-Vicks). Doreen has specific expertise in Drug Establishment Licencing, OTC products, Inspection Readiness and Drug/NHP GMP, was a part-time faculty member of the Seneca College RAQ Program for 10 years and a participant on the NHPD Technical Working Group for the Risk‐Based Approach to Site Licensing. Doreen has also recently initiated work in the area of medical marijuana use.
Shirley Furesz, Ph.D., RAC, Director, Regulatory Affairs Medical Devices
Shirley Furesz is Director, Regulatory Affairs Medical Devices at TPIreg™, a Division of Innomar Strategies Inc. She has been working as a regulatory affairs consultant since 2006 and has extensive experience with medical devices, in vitro diagnostics, companion diagnostics and combination products including those used in orthopedics, gastroenterology, general surgery, dermatology, gynecology, imaging, respiratory, ENT, urology, wound care, dentistry, infection control, and oncology. Shirley received her Ph.D. in the area of vaccine development from the Department of Veterinary Immunology at the University of Guelph. She provides regulatory strategy and manages a wide range of device submissions for Health Canada and other regulatory agencies. Shirley achieved her Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society in 2009. Prior to joining TPIreg™, she was a key member of the medical devices consulting team at Icon plc (previously Mapi Life Sciences, OptumInsight and CanReg Inc.) and has held various research positions at Syn-X Pharma and NoAb BioDiscoveries Inc. in the areas of Point of Care Diagnostic Kit development, Proteomics, Cell Biology, and ADME-Tox testing.