Supply Chain/Manufacturing

Description: This session examines the ongoing efforts to improve supply chain resiliency in the EU and US in ensure patients get the right medicines at the right time. Most supply chains are subject to vulnerabilities such as a lack of diversification of suppliers and external stresses such as geopolitical challenges.

An EMA perspective is provided which outlines how the upcoming new EU pharmaceutical legislation will further support and enhance supply chain resilience, and how the EU Critical Medicines Act aims to secure the supply and increase the production of essential medicines to combat shortages. The updated Union List of Critical Medicines will also be outlined. Furthermore, methodologies for how vulnerabilities are identified in supply chains are also discussed and the use of quantitative data to evaluate production dependency and market concentration.
A United States Pharmacopoeia (USP) perspective provides a US outlook to very similar challenges to supply chains for the US market. Ongoing efforts to map supply chains for products for the US market are described and discussion points include the USP Vulnerable Medicines List as well as initiatives to build resilience.

The session will conclude with a panel discussion and questions and answers from attendees.