CANREG INC.
MOTHERISK
THE SOCIETY OF OBSTETRICIANS AND GYNAECOLOGISTS OF CANADA (SOGC)
DUCHESNAY INC.
CANREG INC.
www.canreginc.com
CanReg’s mission is to provide regulatory services to the healthcare industry that are reliable, of high quality and provide value for cost. Anne Tomalin, BA, BSc, RAC (US, CAN & EU), President of CanReg Inc., founded the company in 1996. She has practiced regulatory affairs exclusively since 1971. Over that time, she has worked with three international pharmaceutical companies to obtain registrations for prescription pharmaceuticals, OTCs and medical devices. Anne worked for 20 years at Searle Canada, being a Business Unit Director when she left to start CanReg. Before joining Searle, she was employed by Hoffmann-La Roche for three years, and Wyeth prior to that. Anne is a graduate of York University with a BSc(Chemistry) and a BA(English).
With more than 100 in-house consultants and staff, CanReg has grown rapidly by serving the regulatory needs of pharmaceutical, biotechnology, medical device and natural health product companies. They provide assistance in drug and device registrations including: new drug submissions, investigational new drug submissions, formulary submissions, DIN applications, medical device registrations, establishment licensing, as well as assistance with related quality systems and training.
CanReg's senior consultants have over 30 years of experience dealing with the FDA, Health Canada and European regulatory agencies. Over the years we have developed long-term relationships with many key decision makers at these regulatory bodies.
MOTHERISK
www.motherisk.org
The Motherisk Program at The Hospital for Sick Children in Toronto, is a clinical, research and teaching program dedicated to antenatal drug, chemical, and disease risk counselling. It is affiliated with the University of Toronto. Created in 1985, Motherisk provides evidence-based information and guidance about the safety or risk to the developing fetus or infant, of maternal exposure to drugs, chemicals, diseases, radiation and environmental agents.
The mandate of the MOTHERISK program is:
- To provide authoritative information and guidance to pregnant or lactating patients and their health care providers regarding the foetal risks associated with drug, chemical, infection, disease and radiation exposure(s) during pregnancy.
- To research unanswered questions on the safety of drugs, chemicals, infection, disease and radiation during pregnancy and breastfeeding, maintain a vital training and educational program in the area of reproductive and developmental toxicology at the undergraduate, graduate and postgraduate levels.
THE SOCIETY OF OBSTETRICIANS AND GYNAECOLOGISTS OF CANADA (SOGC)
www.sogc.org
Founded in 1944, the Society of Obstetricians and Gynaecologists of Canada is comprised of over 3,000 professional members, including gynaecologists, obstetricians, family physicians, nurses, midwives and allied health professionals.
A leading authority on reproductive health care, the SOGC produces national clinical guidelines for both public and medical education on important women's health issues.
The Society's mission is to promote optimal women's health through leadership, collaboration, education, research and advocacy in the practice of obstetrics and gynaecology. The Royal College of Physicians and Surgeons of Canada granted the SOGC full accreditation as a Continued Professional Development provider for physicians and health care providers in Canada. The Society offers an impressive portfolio of professional educational activities including the Annual Clinical Meeting, Continuing Medical Education Programs, e-learning modules and its trailblazing MOREOB patient safety program.
DUCHESNAY INC.
www.duchesnay.com
Duchesnay's mission is to work at filling the existing gap in terms of scientific research, education and evidence-based information, and to develop safe an effective pharmacological solutions for use during pregnancy and lactation. The Company was acquired in 1970 through the entrepreneurship of Louis Boivin, President and owner of Groupe Pharmaceutique Boivin. Up to 1991, the mission of this family-run business was to distribute over-the-counter and prescription medications to Quebec pharmacies.
Towards the end of the 80's, one of Boivin family's members experienced a very difficult pregnancy, which was affecting her health and well-being. Her physician had prescribed a medication to treat this condition, but since her pharmacist did not have access to proper scientific information on medications during pregnancy, he refused to dispense it to her because he believed that the drug was teratogenic. Since the physician and the pharmacist could not agree on this issue, the burden and the stress of the decision to follow the prescribed treatment was left to the pregnant woman.
The Boivin family realized that little scientific or educational information on drugs to be used in pregnancy was available to the Canadian medical community and to women. Therefore, the Boivin family decided to change the Company’s mission and that Duchesnay would be the first pharmaceutical company to dedicate itself exclusively to pregnant women and their newborn, to ensure that expecting women who require pharmacological treatments for pre-existing or pregnancy-related diseases have access to proper counselling and to medications that are proven safe for them and for their newborns. Since then Duchesnay has evolved as a research-based pharmaceutical company with the vision to improve women's quality of life during pregnancy and lactation while reducing the number of birth defects and impacts on their offsprings.