Module 1 2021

Strategic Planning in Regulatory Affairs USA: Strategic Regulatory Considerations • 30 June 2021 • J. Margaretha Oortgiesen, PhD • Senior Clinical Program Director, UCB BioSciences

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Learning outcomes

USA • BACKGROUND: The US FDA, mission, organization, scope of products

• TACTICAL CONSIDERATIONS: IND/NDA applications & implications for non-US companies

• STRATEGIC CONSIDERATIONS: Regulatory mechanisms, working with the FDA

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