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Case Studies
The following posts are in no particular order. They are purposely randomized.
Risk-based decision making framework
The Alliance of Blood Operators (ABO) needed a coherent risk management framework to guide decision-making on the delivery of blood services by its member organizations, which would help produce consistent decision-making processes and outcomes across the different national jurisdictional and regulatory structures. The RBDM approach was meant to support a shift in risk decision-making in national blood services organizations from one focused on minimizing all risks to blood quality and supply, with little concern for costs, to a risk-based approach in which resources are allocated according to risk and the application of financial resources and management rigour is proportional to the risk they are addressing.
Read More Evaluation of Toxicological Data on Experior
To support the evaluation of a new veterinary pharmaceutical product intended for use in bovines, a scientific review was requested of submitted toxicological data related to the active compound LY488756. This compound, proposed under the product name Experior, had been advanced for registration based on its claimed selective action on β3-adrenergic receptors and a lack of mutagenic, carcinogenic, or teratogenic effects. Given its potential entry into the human food supply via meat residues, an independent expert analysis of the submission was deemed necessary to determine its safety.
Read More Canadian Recipient Hemovigilance System Renewal Consensus Conference
Following the planned closure of the Blood Safety Contribution Program (BSCP), support was needed to help define the structure, elements, and functions of a renewed national recipient hemovigilance system for Canada. The work centred on preparing the transfusion medicine community, federal and provincial/territorial partners, blood operators, and patient representatives to develop recommendations for a future system that could maintain national coordination, support blood and patient safety, and preserve trust in Canada’s blood system.
Read More Evaluation of Drug Recall Communication and Risk Determination Processes
In response to public and ministerial concerns about the timeliness and adequacy of information shared during a major prescription drug recall, Health Canada commissioned an independent review to assess its response to the event. The situation involved a recall of the oral contraceptive Alysena, issued due to packaging issues that altered the intended dosing sequence and raised questions about potential unintended health risks.
Read More Systematic Review of Artificial Sweeteners and Health Risks
A comprehensive systematic review was undertaken to assess experimental evidence regarding the potential health risks associated with artificial sweeteners, specifically focusing on cancer and pre-term delivery. The client sought a rigorous analysis of both in vivo and in vitro experimental studies to better understand any biological associations or mechanisms that might underpin observed health outcomes.
Read More Risk-Based Optimization of Enforcement Activities
A federal agency required scientific support to enhance the effectiveness of its environmental enforcement activities. This involved identifying and analyzing the risk factors—both environmental and human health-related—that contribute to the likelihood and impact of regulatory offences. The objective was to develop a structured approach to prioritize enforcement actions under key legislative frameworks including the Canadian Environmental Protection Act, the Fisheries Act, the Species at Risk Act, and others.
Read More Analysis in Support of Risk-Based Decision-Making for the Alberta Safety Codes Council
An independent regulatory organization responsible for oversight of Alberta’s safety codes system sought to strengthen its capacity for risk-based decision-making. The organization aimed to ensure that regulatory actions—particularly in the area of petroleum storage tanks—were guided by clear, evidence-based prioritization methods that protect public safety while making effective use of resources. The project began with…
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