DIA 2020 Global Annual Meeting

This event is now offered in a new entirely virtual format.

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Regulatory Agility During the COVID-19 Pandemic

Session Chair(s)

Christine Moore, PhD

Executive Director, Global External Advocacy and Standards

Organon & Co., United States

The current health crisis has necessitated maximum agility from both regulators and manufacturers to ensure continued supply of quality products for patients. In this session, regulators from multiple health authorities will discuss new regulatory mechanisms and flexibility of regulatory expectations to balance risk and availability.

Learning Objective : Describe the challenges facing manufacturers related to the current COVID pandemic; Discuss regulatory approaches used by health authorities to endure continued availability of quality medicines for patients.

Speaker(s)

COVID19 Regulatory Flexibilities: MHRA Update

David Churchward, MS

Lonza Biologics, United Kingdom

Global Head Sterility Assurance, Cell and Gene Technologies

Regulatory Agility During the COVID-19 Pandemic: FDA Update

Jeannie David, MS

FDA, United States

Senior Program Management Officer, Drug Shortage Staff, CDER

Regulatory Agility During the COVID-19 Pandemic: EU Regulatory Authorities Approach

Noël Wathion, RPh

European Medicines Agency, Netherlands

Deputy Executive Director

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