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.

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…

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.

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.

To support the refinement and implementation of its ecological risk guidance, a federal department responsible for marine conservation engaged expert assistance in risk communication. The primary objective was to ensure that the national guidance for ecological risk assessment—developed as part of the department’s marine spatial planning and marine protected areas initiatives—could be effectively communicated to diverse internal and external audiences.

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.

To support the quality and defensibility of regulatory decision-making under the Canadian Environmental Protection Act, 1999 (CEPA), Health Canada engaged Risk Sciences International to coordinate an independent external peer review of the Draft Screening Assessment Report (DSAR) for Selected C3-C5 Alcohols, focusing specifically on tert-butanol (CAS RN 75-65-0). This group of substances had been prioritized for risk assessment based on potential human health concerns.

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.

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.

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.