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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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