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Building a Regulatory Landscape to Support CMC Innovation
Session Chair(s)
Demetra Macheras, MBA
Director, Regulatory Policy and Intelligence - Regulatory Affairs
AbbVie, United States
Senior leaders from industry and regulatory agencies will discuss the role of cooperation across regulatory bodies to facilitate innovation in the CMC/product quality sector. Senior leaders will discuss how, despite various internal and external pressures, an agile path forward can be found to advance innovative and high quality medicines.
Learning Objective : Describe initiatives to streamline regulatory assessment/inspection; Illustrate how regulatory initiatives can facilitate innovation in CMC; Compare perspectives from senior leaders regarding regulatory initiatives and reguatory advancements.
Speaker(s)
Panelist
Jennifer McCafferty, PhD
Merck, United States
Senior Vice President, Head of CMC-Regulatory and MRL Quality Assurance
Panelist
Representative Invited
FDA, United States
Panelist
Representative Invited
European Medicines Agency, Netherlands
Panelist
Representative Invited
Health Products Regulatory Authority , Ireland
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