Canada and European Union to share therapeutic risk management strategies
Montreal, December 7, 2006 – In a move that will further extend its international reach, the Faculty of Pharmacy of the Université de Montreal announces a collaboration with the European Medicines Agency (EMEA) in the field of drug risk management. The European Union’s drug regulatory agency will access Canada’s leading expertise in balancing the risks and benefits of marketed drugs. Under the Direction of acting Dean of the Faculty, Dr. Pierre Moreau, Université de Montréal Professor Yola Moride, PhD, FISPE, will serve as a National Expert at the EMEA’s London offices through a secondment exchange program.
A risk management program spells out a strategy that aims to maximize health benefits while minimizing known risks. For example, drug utilization studies may be planned to monitor patterns of medication use in a real-life setting and, if concerns are raised, patients who may be more susceptible to an adverse drug reaction could be required to undergo, for example, monthly blood tests prior to getting their next prescription refilled. Risks cannot only be identified in pre-market clinical trials but also when a treatment is commercially available. The types of patients and treatment patterns that offer the least favorable risk/benefit profile are identified and this knowledge is formalized and implemented in a risk management program. Moride expects that the use of such programs will be almost routine for the next generation of pharmacotherapy. The nature of each risk management program is likely to be unique to each therapy option. Health risks can present themselves in myriad forms; consequently, patients, physicians, the drug industry and its regulators are all key stakeholders.
While at the European Medicines Agency in London, Prof. Moride will work at transferring certain best practices designed in Canada to the European Union. In announcing the creation of a joint research programme, Professor Moride commented on the Canadian and European situation. The EU and Canada both have centralized drug approval mechanisms. Both also have decentralized systems for drug coverage decisions. Each EU Member State and each Canadian Province makes its own decision to pay or not to pay for a particular prescription drug. “Although Health Canada approves new drugs mainly based on clinical trial data, it is the drug payers - the provinces and private insurers – that are rather well positioned to identify risks seen within their covered populations. In the future, these multiple stakeholders will have to evolve and expand their understanding of the management of health risks related to the consumption of medications.”
“The EU has made great progress towards implementing drug safety studies across its diverse member states. The exchange programme with the EMEA will transfer Canadian expertise in pharmaceutical epidemiology to the EU. Canada will benefit by learning the EU’s successful strategies for the deployment of risk management studies across the Canadian Federation.”
“The prescription and medical service databases maintained by each province as part of the public health care payment system are significant resources of risk/benefit data. These should position Canada as a key provider of therapeutic risk management technologies.”
Associate Professor at the Faculty of Pharmacy, Université de Montréal, Professor Moride was recently voted president-elect of The International Society for Pharmacoepidemiology (ISPE). She holds appointments as Adjunct Professor at McGill University, Visiting Professor at the University of Bordeaux, and as Project Director at the SMDB Jewish General Hospital in Montreal. She is also Project Director at the Université de Montréal’s Groupe de recherche en gestion thérapeutique. Prof. Moride is an internationally renowned pharmaceutical epidemiologist who has conducted research in Canada and various countries in Europe, and is consultant to the pharmaceutical industry and regulatory agencies, such as the European Medicines Evaluation Agency (EMEA) and Health Canada, on the complexities of drug safety research.
When she assumes her three-year term as president of IPSE in August 2007, Moride will focus on encouraging scientific excellence in the area of pharmacoepidemiology, drug safety, and therapeutic risk management, as well as promoting dialogue between pharmaceutical industry, regulatory agencies, academia, and the public.
About Université de Montréal
Founded in 1878, the Université de Montréal today has 13 faculties and together with its two affiliated schools, HEC Montréal and École Polytechnique, constitutes the largest centre of higher education and research in Québec, the second largest in Canada, and one of the major centres in North America. It brings together 2,400 professors and researchers, accommodates more than 55,000 students, offers some 650 programs at all academic levels, and awards about 3,000 masters and doctorate diplomas each year.
The International Society for Pharmacoepidemiology (ISPE) is the international organization dedicated to advancing the health of the public by providing a forum for the open exchange of scientific information and for the development of policy; education; and advocacy for the field of pharmacoepidemiology, including pharmacovigilance, drug utilization research, and therapeutic risk management. http://www.pharmacoepi.org/
Source: Yola Moride
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Faculty of Pharmacy
Université de Montréal
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