Strengthening Drug Shortage Frameworks: Global Perspectives and Regional Action
Complimentary
Learning Level: Intermediate
Time: 1000 - 1130 CET / 0400 - 0530 ET
Session Length: 1 hour
The ISPE webinar will serve to introduce the ISPE Drug Shortages Initiative and highlight ISPE drug shortage prevention tools to assist manufacturers and regulators in strengthening and harmonizing drug shortage prevention efforts globally. The webinar will feature insights from various regulators that have implemented drug shortage frameworks, as well as industry perspectives on drug shortage prevention, reporting and managing distribution/access challenges.
Discussion topics will include the following:
- ISPE Drug Shortage Initiative, including the ISPE Drug Shortage Prevention Model and Assessment and Prevention Tool in development
- Regulator perspective: implementing a drug shortage regulatory framework
- discuss EMA and NPRA drug shortage frameworks
- challenges and opportunities
- overview of HERA: addressing drug shortages
- Industry perspective: drug shortage prevention and reporting
- drug shortage initiatives underway in the AP region
- discuss distribution/access challenges
Participants will have an opportunity to ask questions of the panel members
ISPE Webinar Takeaways
- Global Drug Shortage Prevention Frameworks: Introduction to ISPE’s Drug Shortage Initiative, including the Prevention Model and new Assessment & Prevention Tool to strengthen global resilience.
- Regulatory & Industry Insights: EMA, NPRA, and HERA perspectives on implementing shortage frameworks; industry strategies for prevention, reporting, and managing distribution/access challenges.
- Collaboration & Harmonization: Emphasis on aligning regulatory and industry efforts worldwide, with interactive Q&A to address practical challenges and opportunities
Learning Objectives
- Gain an understanding of the ISPE Drug Shortages Prevention Model (DSPM) and its upcoming assessment and prevention tool, and learn how these resources can assist manufacturers and regulators in strengthening and harmonizing drug shortage prevention efforts globally.
- Hear from global health authority regulators who have implemented drug shortage frameworks, gaining insights into their practical application and the challenges faced in regulatory environments.
- Explore industry perspectives on preventing drug shortages, reporting mechanisms, and managing distribution and access challenges.
