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The following posts are in no particular order. They are purposely randomized.

Case Studies

Risk-Based Decision Making (RBDM) Compliance and Enforcement

Innovation, Science and Economic Development Canada (ISED), through its Spectrum Management Innovation Directorate, sought support in applying risk-based decision making (RBDM) across its compliance and enforcement responsibilities. The department was looking for a structured and data-driven approach to prioritize regulatory actions in a way that reflects risks to the public interest.
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Case Studies

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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Case Studies

Risk Assessment of the Impact of Lethality Standards on Salmonellosis from Ready-to-Eat (RTE) Meat and Poultry Products

To support regulatory decision-making, a comprehensive risk assessment was conducted to evaluate how varying lethality performance standards would impact the public health burden of salmonellosis associated with Ready-to-Eat (RTE) meat and poultry products. The primary objective was to quantify the expected number of cases of illness under different reductions in Salmonella presence across a broad spectrum of RTE product categories.
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Case Studies

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.
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Case Studies

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.
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Case Studies

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.
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