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Preparing Medical Information for Emergency Use Authorization (EUA) to a Full Launch During the COVID-19 Pandemic
Session Chair(s)
Truc Dinh, PharmD
Associate Director, Global Medical Information
Gilead Sciences, Inc., United States
Supporting Emergency Use Authorization (EUA) during the unprecedented times of a global pandemic is challenging. A panel discussion about Emergency Use Authorization (EUA) will bring together key leaders in Medical Information across the pharmaceutical industry. The industry leaders will share the hurdle of regulatory requirements in each country and overcoming of these challenges in preparation for EUA in amidst of a global pandemic. Panelist will share key learnings from a successful global MI product launch during the COVID-19 pandemic including scientific response document planning, collaboration with internal partners, communicating key metrics and insights with internal stakeholders, scaling-up internal resources and training, and supporting global MI operations. Sharing key learnings from their EUA experiences will help to inform our industry with how to adapt key strategic planning initiatives for Medical Information to meet the challenges of EUA.
Learning Objective : Discuss the differences between medical support for Emergency Use Authorization (EUA) and traditional product approval; Describe best practices for Medical Information (MI) strategic planning for EUA including MI standard response documents, FAQs, internal trainings, and MI contact center operations. • Describe key learnings for MI during pre-EUA, after EUA approval, and the transition to approval
Speaker(s)
Panelist
Laura Miesle, PharmD
Eli Lilly and Company, United States
Consultant, Global Medical Information - COVID-19 and Biomedicines
Panelist
Barbara Maria Bonetti, PharmD
Pfizer Inc, United States
Director, Medical Customer Interface
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