An ad hoc planning committee of the National Academies of Sciences, Engineering, and Medicine will organize a public workshop to explore approaches for preventing, detecting, and responding to substandard and falsified (SF) medical products. The workshop will consider factors that enable SF medical products to persist in global supply chains, including regulatory and enforcement challenges, supply chain vulnerabilities, and gaps in international coordination. It will also explore models for multistakeholder engagement and collaboration that have been used to address complex cross-sector challenges.
The public workshop may feature presentations and discussions on:

• Vulnerabilities in supply chains and gaps in current prevention, detection, and response efforts, including the strengths and limitations of existing programs to curb the export and distribution of SF medical products;
• The design, governance, and operational features of multistakeholder models that support sustained engagement, information sharing, accountability, and effective implementation;
• Alternative and complementary approaches, including bilateral cooperation mechanisms, regulatory and enforcement strategies, and other models for coordinated action in the current international policy environment;
• Considerations, trade-offs, and near-term opportunities for strengthening efforts to combat substandard and falsified medical products; and
• Potential implications for U.S. Food and Drug Administration programs, authorities, and partnerships.

The planning committee will organize the workshop, develop the agenda, select and invite speakers and discussants, and moderate or identify moderators for discussions. A proceedings-in-brief of the presentations and discussions at the workshop will be produced by a designated rapporteur in accordance with institutional guidelines.