DIA 2021 Global Annual Meeting

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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 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, Global 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

Centre for Innovation in Regulatory Science (CIRS), United Kingdom

Senior Advisor

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