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Session 3: Quality Considerations for Generic Drug-Device Combination Products
Session Chair(s)
Susan Rosencrance, PhD
Acting Director, Office of Generic Drugs, CDER, FDA, United States
This session will focus on quality considerations for generic drug-device combination products. Generic drug-device combination products have certain unique requirements to demonstrate pharmaceutical equivalence. These include formulation and device aspects as well as the associated control strategy to ensure these products meet regulatory requirements for approval. In addition, the presentations in this session will provide scientific discussion on quality issues related to various drug-device combination products as well as manufacturing related issues.
Learning Objective :
Speaker(s)
Brock Roughton
Acting Quality Assessment Lead, OPQ, CDER, FDA, United States
Product Quality Considerations for Transdermal Delivery Systems (TDS) and Metered Dose Inhalers (MDIs)
Intira Coowanitwong
Acting Quality Assessment Lead, OPQ, CDER, FDA, United States
Product Quality Considerations for Transdermal Delivery Systems (TDS) and Metered Dose Inhalers (MDIs)
Bing Cai, PhD
Division Director, OPQ, CDER , FDA, United States
Quality Expectations for Injectable and Other Liquid-Based Generic Combination Products
James Jefferis Norman, PhD
Senior Chemist, OPF, OPQ, CDER, FDA, United States
Transdermal Systems: Considerations for the Manufacturing Process Assessment– FDA Perspective
Steven Hertz, MBA, MS
Consumer Safety Officer, Office of Pharmaceutical Quality, CDER , FDA, United States
Facility Inspection Considerations for Generic Drug-Device Combination Products
Alan Stevens, MS
Global Head, Complex Devices and Drug Delivery Systems, AbbVie, United States
Device Design and Quality Evaluation for Generic Combination Products
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