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Accelerating US Based Domestic Manufacturing by Leveraging Innovative Regulatory Concepts
Session Chair(s)
Joseph Kutza, PHD
Senior Director Regulatory Policy - CMC
Eli Lilly and Company, United States
The recent focus by the US government to increase US-based pharmaceutical manufacturing has created opportunities to revisit the regulations and guidelines that lead to the lengthy time that it takes to construct or expand a manufacturing facility.
Learning Objective : Discuss critical path items that lead to extended construction and regulatory approval timelines; Describe how FDA's innovative regulatory concepts address these challenges; Identify the similarities and differences between bolstering domestic manufacturing by onshoring manufacturing to established facilities versus new or expanded US based facilities.
Speaker(s)
Building U.S. Biopharmaceutical Manufacturing Workforce Capacity: Challenges, Opportunities, and Innovations
John Balchunas, MSC
National Institute for Innovation in Manufacturing Biopharma, United States
Workforce Director
Innovative Regulatory Approaches to Increasing US-based Pharmaceutical Manufacturing
Cecilia Tami, PHD
Genentech, A Member of the Roche Group, United States
Head US CMC Regulatory Policy
Modernizing Oversight: Enabling the Future of U.S.-Based Pharmaceutical Manufacturing
Lisa Wright, MS
Novo Nordisk A/S, United States
Director Regulatory Policy
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