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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; Recognize how regulatory initiatives can facilitate innovation in CMC; State comparing perspectives from senior leaders regarding regulatory initiatives and regulatory advancements.
Speaker(s)
Panelist
Leanne Hickman
Eli Lilly and Company, United States
Senior Vice President, Global Quality Analytical Sciences & QC Operations
Panelist
Evdokia Korakianiti, PhD, MSc
European Medicines Agency, Netherlands
Head of Quality and Safety of Medicines
Panelist
Ingrid Markovic, PhD
United States
Independent Expert
Panelist
Jennifer McCafferty, PhD
Merck, United States
Senior Vice President, Regulatory CMC and Quality Assurance
Panelist
Sean Barry, PhD
Health Products Regulatory Authority (HPRA), Ireland
Senior Pharmaceutical Assessor
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