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

Case Studies

EFSA Framework for Problem Formulation

To enhance the methodological rigour of its scientific assessments, EFSA sought to develop a standardised framework for problem formulation (PF) within its non-application scientific assessment protocols. The goal was to support the planning phase of these assessments by establishing a structured, reproducible approach for translating mandates into scientifically answerable questions. This included creating a framework…
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Case Studies

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.
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Case Studies

Finalization of Risk Assessment on Secure Opioid Dispensing Devices

To support decision-making around modifications to opioid agonist treatment delivery, a detailed risk assessment was requested to evaluate the integration of secure dispensing devices for direct patient access to hydromorphone. Building on a previously conducted preliminary assessment, the work required a structured framework that would articulate hazards, assess likelihoods and risks, and identify mitigation strategies associated with introducing these devices into service delivery models.
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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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Case Studies

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.
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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

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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Case Studies

International newspaper rethink

The original mandate aimed to find a new direction for the world renowned International Herald Tribune just as both the World Wide Web was in its infancy, and the newspaper faced increased competition from international and regional editions of established newspapers and magazines such as The Economist, The Wall Street Journal, and The Financial Times.
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