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Emergency Use Pathways: What Leanings from COVID-19 Can be Generalized to Address Unmet Medical Needs?
Session Chair(s)
Lawrence Liberti, PhD, RAC
Director, D.K. Kim International Center for Regulatory Science
The Kim Center/ USC DRQS, 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.
Speaker(s)
Industry Perspective on Emergency Use Pathways: Opportunities and Challenges
Angelika Joos, MPharm
MSD, Belgium
Executive Director, Science & Regulatory Policy
Emergency Pathways for Access to COVID-19 Drugs and Vaccines in Canada
Celia Lourenco, PhD
Health Canada, Canada
Director General, Biologic and Radiopharmaceutical Drugs Directorate, HPFB
COVID-19-Related EUPs in the Emerging Markets: A Role in Unmet Medical Needs
Mario Alanis, PhD
Erudee Foundation, Frpath, Mexico
Senior Advisor