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Thursday, July 1 • 11:30am - 12:30pm
#426 SL: Emergency Use Pathways: What Leanings from COVID-19 Can be Generalized to Address Unmet Medical Needs?

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-653-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.

Chair

Lawrence Liberti, PhD, RPh, RAC

Speaker

Industry Perspective on Emergency Use Pathways: Opportunities and Challenges
Angelika Joos, MPharm

Emergency Pathways for Access to COVID-19 Drugs and Vaccines in Canada
Celia Lourenco, PhD

COVID-19-Related EUPs in the Emerging Markets: A Role in Unmet Medical Needs
Mario Alanis, PhD



Speakers
avatar for Lawrence Liberti

Lawrence Liberti

Adjunct Research Professor, Temple University School of Pharmacy, Reg. Affairs and QA Grad Program, United States
Dr Liberti has worked in pharmaceutical regulatory affairs, communications and clinical R&D for the past four decades. Since 2009 he has served as the Executive Director of CIRS (the Centre for Innovation in Regulatory Science, Ltd, forming part of Clarivate Analytics). He has been... Read More →
MA

Mario Alanis

Senior Advisor, Centre for Innovation in Regulatory Science (CIRS), United Kingdom
avatar for Angelika Joos

Angelika Joos

Executive Director, Global Regulatory Policy, Merck Sharp & Dohme (Europe) Inc., Belgium
Angelika Joos is a trained pharmacist. She is responsible for Regulatory Policy issues within MSD's Global Regulatory Affairs and Clinical Safety department. This role includes identifying regulatory policy priorities that align with MSD’s business priorities, leading cross-functional... Read More →
avatar for Celia Lourenco

Celia Lourenco

Director General, Biologic and Radiopharmaceutical Drugs Directorate, HPFB, Health Canada, Canada
Celia Lourenco, PhD is the Director General of the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) of the Health Products and Food Branch of Health Canada. She was previously the Senior Executive Director of the Therapeutic Products Directorate (TPD) and held other management... Read More →


Thursday July 1, 2021 11:30am - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Forum