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DIA 2021 Global Annual Meeting
Emergency Use Pathways: What Leanings from COVID-19 Can be Generalized to Address Unmet Medical Needs?
Lawrence Liberti, PhD, RPh, RAC
- Adjunct Research Professor
- Temple University School of Pharmacy, Reg. Affairs and QA Grad Program, United States
The need to respond to COVID-19 has revealed the importance of emergency use pathways (EUPs). We compare characteristics of EUPs, identify regulatory best practices and consider how these can be generalized to address unmet medical needs.
Learning Objective : Discuss similarities and differences across emergency use pathways (EUPs); Identify regulatory best practices that can be learned from these EUPs; Describe how these best practices can be generalized to an effective and efficient regulatory process.
Industry Perspective on Emergency Use Pathways: Opportunities and Challenges
Angelika Joos, MPharm
- Executive Director, Global Regulatory Policy
- Merck Sharp & Dohme (Europe) Inc., Belgium
Emergency Pathways for Access to COVID-19 Drugs and Vaccines in Canada
Celia Lourenco, PhD
- Director General, Biologic and Radiopharmaceutical Drugs Directorate, HPFB
- Health Canada, Canada
COVID-19-Related EUPs in the Emerging Markets: A Role in Unmet Medical Needs
Mario Alanis, PhD
- Senior Advisor
- Centre for Innovation in Regulatory Science (CIRS), United Kingdom