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Case Studies
The following posts are in no particular order. They are purposely randomized.
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 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 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 Risk-Based Decision-Making (RBDM) Support for Plasma Supply / Sufficiency
Facing renewed challenges in securing a reliable domestic plasma supply, Canadian Blood Services sought support to apply a Risk-Based Decision-Making (RBDM) framework. The objective was to assess the value and implications of expanding domestic plasma collection and processing capacity in response to the emergence of commercial plasma operations that export plasma to international markets.
Read More Measuring impact of zoonotic animal diseases in Canada
A large number of domestic and foreign animal diseases with zoonotic health impacts to humans must be managed carefully to prevent disease transmission and spread. Risk management decisions often involve the comparison of different types of risk and the cost-effectiveness of different control measures for reducing risk. This requires that different types of risk be assessed in a consistent manner to allow cross-comparisons. The use of disability adjusted life years (DALYs) as a measure of the burden of human disease from domestic and foreign animal pathogens was completed for several zoonoses in Canada.
Read More Evaluation of Health Product Risk Communication Tools
To enhance the effectiveness of health product risk communications, a systematic evaluation was requested to assess the performance of key instruments used to disseminate safety and efficacy information. The aim was to support efforts under the Evaluating the Effectiveness of Risk Communications (EERC) initiative by identifying methodologies and metrics that could measure how well these tools reach their intended audience, how clearly messages are conveyed, and what impact they have on knowledge, attitudes, and behaviours.
Read More Pickering Nuclear Facility Re‑licensing
The client sought support to finalize a Commission Member Document (CMD) for the re‑licensing of a nuclear facility. Recognizing the complexity and sensitivity of reactor re‑licensing, they requested assistance in crafting communication materials that were both technically comprehensive and accessible to regulatory bodies and broader audiences. The work included drafting a clear and well‑structured CMD,…
Read More Technical Support for Risk-Based Decision Making (RBDM)
To enhance the oversight of cannabis production under its regulatory mandate, the Cannabis Directorate sought expert support in developing a risk-based decision-making framework tailored to its compliance and enforcement responsibilities. The directorate aimed to better assess and respond to non-conformance with Good Production Practices (GPP) as defined in the Cannabis Act and Regulations, using a data-driven approach.
Read More Developing a Risk-Based Compliance Framework for Digital Service Delivery
The Financial Consumer Agency of Canada (FCAC) engaged Risk Sciences International to provide strategic advisory services aimed at enhancing its regulatory compliance model through risk-based methodologies. FCAC’s objective was to explore new approaches that would integrate digital tools and data-driven strategies into its compliance activities, in line with its strategic goal of strengthening consumer protection in financial markets.
Read More Validation and Optimization of the Computational Tool for the Microbial Risk Assessment Framework (MRAF)
To support more consistent and quantitative assessments of new micro-organisms under the Canadian Environmental Protection Act, Health Canada's New Substances Program (NSP) sought to refine the tools and processes within its Microbial Risk Assessment Framework (MRAF). The NSP had previously collaborated with RSI to review and modernize the MRAF and develop a supporting computational tool. However, further work was required to validate the tool and ensure it aligned with current program needs and regulatory expectations.
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