As the world attempts to emerge from the pandemic and return to activity reminiscent of pre-pandemic times, there are still uncertainties remaining related to supply chain stability. Many valuable lessons can be learned from the pandemic and applied to planning for the possibility of another pandemic, or even a tripledemic. Some global Health Authorities have been active in developing guidance and recommendations to mitigate disruption in the supply chain and secure patient access to critical medicines based on these recent learnings in an effort to improve planning and preventative measures. Additionally, some governments have imposed legislative measures to encouraging onshoring as a protective measure to insulate domestic supply chains from disruption. In parallel, to appreciate and align with regulatory efforts to address shortages and supply chain instability, the ISPE Drug Shortages Initiative team has developed expanded guidance on the quality, technical, and regulatory aspects of drug shortage prevention. Regulators and experts will present experiences related to securing supply chain, mitigating drug shortages, and efforts to proactively be prepared for the possibility of a future pandemic.
As a result of this session participants will gain:
Insights from experiences endured during the SARS-CoV-2 pandemic and potentially longer-lasting impacts on the global supply chain, from both regulatory and industry perspectives.
Overviews of regulatory and industry initiatives which aim to achieve further transparency across the supply chain.
An understanding of HA perspectives related to regulatory expectations to mitigate drug shortages and supply chain strain (e.g., FDA, EU).
Opportunities to interact with global regulators (including FDA and European Commission) and industry in a Q&A session and informally at the conference.
10:00 – 10:25: Updates on Drug Shortages and Supply Chain Challenge by Emily Thakur
10:25 – 10:40: The ISPE Drug Shortages Prevention Model (ISPE DSPM) – Guidance for Drug Shortage Prevention Excellence by Diane Hustead
10:40 – 10:55: Updates Regarding European Commission Drug Shortage Prevention and Mitigation by Wolfgang Philipp
10:55 – 11:10: EMA Extended Mandate in the Management of Medicine Shortages by Monica Dias
11:10 – 11:30: Question and Answer/Panel Discussion
Head of Supply and Availability of Medicines and Medical Devices,
SVP, Head of Global Strategic Compliance Consulting,