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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)
Product Quality Considerations for Transdermal Delivery Systems (TDS) and Metered Dose Inhalers (MDIs)
Brock Roughton
FDA, United States
Acting Quality Assessment Lead, OPQ, CDER
Product Quality Considerations for Transdermal Delivery Systems (TDS) and Metered Dose Inhalers (MDIs)
Intira Coowanitwong
FDA, United States
Acting Quality Assessment Lead, OPQ, CDER
Quality Expectations for Injectable and Other Liquid-Based Generic Combination Products
Bing Cai, PhD
FDA, United States
Division Director, OPQ, CDER
Transdermal Systems: Considerations for the Manufacturing Process Assessment– FDA Perspective
James Jefferis Norman, PhD
FDA, United States
Senior Chemist, OPF, OPQ, CDER
Facility Inspection Considerations for Generic Drug-Device Combination Products
Steven Hertz, MBA, MS
FDA, United States
Consumer Safety Officer, Office of Pharmaceutical Quality, CDER
Device Design and Quality Evaluation for Generic Combination Products
Alan Stevens, MS
FDA, United States
Acting Division Director, Division of Drug Delivery, General Hospital and Human
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