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.
Brenda Gryfe, M.Sc.Phm., Director, Regulatory Affairs.
Brenda is a pharmacist with over 25 years' experience in the pharmaceutical industry in a variety of therapeutic areas, including women's health and cardiology. Before joining Therapeutic Products Inc., in 2014, Brenda has held positions in Regulatory Affairs, Medical Affairs, Medical Communications, Pharmacovigilance and Clinical Research. She has a business-focused understanding of Regulatory Affairs, gained from experience across several companies, including Procter and Gamble. Brenda has guided Regulatory teams through a variety of regulatory processes, including strategically complex NDSs, CTAs, DIN applications, and Priority Review Requests. She also provides support to promotional material development teams with regulatory advice and review services for the unique drug advertising environment in Canada. Since doing research in seniors' understanding of prescription drug labels at the University of Toronto, Brenda retains a particular interest in drug labeling, including patient education materials.
Michelle De La Croix, RAC, Senior Director, Regulatory Affairs
Previously with CanReg Inc., Michelle has over 14 years of experience with strategic regulatory advice for Clinical Trial and Clinical Trial Applications for a large variety of products in multiple therapeutic indications. Michelle has a Diploma in Nursing, and has worked as a Registered Nurse in hospital environments in Medical-Surgical, Telemetry, Oncology and Paediatrics. Michelle is a member of Society of Clinical Research Associates (SOCRA), CAPRA and RAPS and has a current RAC in Canadian Regulatory Affairs.
Krystyna Bienkiewicz, B.Sc., Director, Regulatory Affairs
Previously from Novopharm, Boehringer Ingelheim and Searle, with almost 20 years of experience in Regulatory Affairs and Regulatory submissions to develop, submit and gain approval of New and Clinical Drug Submissions including foods and nutritional products. Krystyna has been an active member of CAPRA including positions on the board of directors. Most recently she has served as the CAPRA Education Day Chair for the past 5 years.
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.
Brian Randall, BSc., Hons, Biology, Director, Quality Assurance
Brian has joined TPIreg as Director, Quality Assurance. Brian is well versed in QA and consulting. He has worked for over 8 years as a consultant in QA. In addition, Brian has worked in the QA arena in the pharmaceutical industry for over 10 years.