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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)
EU Toolbox Guidance for PRIME Products
Marcel Hoefnagel, DrSc, PhD, MSc
Medicines Evaluation Board , Netherlands
Senior Assessor Biopharmaceuticals
GDUFA II Pre-ANDA Program: A Tool to Accelerate CMC Development of Complex Generics
Fang Yuan, PhD
FDA, United States
Chemist, OLDP, OPQ, CDER
Applying CMC Acceleration with Considerations for Lifecycle Impact
Lisa DeCardenas
Genentech, A Member of the Roche Group, United States
Regulatory Program Director
CMC Flexibility Applied to COVID-mRNA Vaccine Development
Roger Nosal, PhD
Pfizer Inc, United States
Vice President, Head of Global CMC
Panelist
Dolores Hernan Perez de la Ossa, PhD
European Medicines Agency, Netherlands
Quality Specialist - Pharmaceutical Quality Office
Panelist
Laurie Graham
FDA, United States
Director, DIPAP, OPPQ, OPQ, CDER
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