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Supporting Quality/CMC Development in Early Access Approaches (PRIME/Breakthrough Designation)
Session Chair(s)
Veronika Jekerle, PHD, RPH
Head of Pharmaceutical Quality, European Medicines Agency, Netherlands
Scientific and regulatory tools to allow for risk-based flexibility of quality data packages and their application to a number of different innovative products including complex generics, and COVID-19 vaccines, will be discussed in this session.
Learning Objective : Describe regulatory and scientific flexibilities in CMC aspects for product development as summarized in the recently published draft EU Toolbox guidance to support early access approaches; Discuss FDA’s perspective on the role of GDUFA II Pre-ANDA program on accelerating CMC development of complex generics; Discuss how such principles have been applied to innovative developments (COVID-19 mRNA vaccines); Assess future consideration, including lifecycle impact, by both regulators and industry.
Speaker(s)
Marcel Hoefnagel, DRSC, PHD, MSC
Senior Assessor Biopharmaceuticals, Medicines Evaluation Board , Netherlands
EU Toolbox Guidance for PRIME Products
Fang Yuan, PHD
Chemist, OLDP, OPQ, CDER, FDA, United States
GDUFA II Pre-ANDA Program: A Tool to Accelerate CMC Development of Complex Generics
Lisa DeCardenas
Regulatory Program Director, Genentech, A Member of the Roche Group, United States
Applying CMC Acceleration with Considerations for Lifecycle Impact
Roger Nosal, PHD
Vice President, Head of Global CMC, Pfizer Inc, United States
CMC Flexibility Applied to COVID-mRNA Vaccine Development
Dolores Hernan Perez de la Ossa, PHD
Quality Specialist - Pharmaceutical Quality Office, European Medicines Agency, Netherlands
Panelist
Laurie Graham
Director, DIPAP, OPPQ, OPQ, CDER, FDA, United States
Panelist
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