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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 Methodology for Developing Risk Significance Insights
The project centered on supporting the development of a methodology that could eventually be implemented as an Artificial Intelligence (AI) or Machine Learning (ML) process. The objective was to help formalize and potentially automate how professional judgment is applied when determining the risk significance of non-compliant findings within the Canadian nuclear regulatory framework. Specifically, the…
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 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 Airport traffic flow and signage review
An international airport authority sought a comprehensive assessment of passenger and vehicle traffic flow after receiving complaints of confusion and safety concerns. Reports indicated that passengers were struggling to interpret signage, often stopping too long to process graphics, which caused line-ups and delays. Lighting problems compounded the issue, with signs placed in poorly illuminated areas.…
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) 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.
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,…
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