| Free Webinar Session
Biologics R&D and Drug Delivery System | | |
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| | March 30
19:00 - 19:45
(GMT+8 China Time)
English & Chinese | | | | Compatibility Research of Drug and Packaging | | |
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| | Cheng Xiao Zhen
Extractables & Leachables,
Manager, Baxter Healthcare | | | What you will learn - The latest regulations and requirements for extractables and leachables
- Compatibility research of components used in biopharmaceutical manufacturing
- Case study: Component compatibility in drug production
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| | March 30
19:45 - 21:00
(GMT+8 China Time)
English & Chinese | | | Interchangeability Guidelines for Your Biosimilar Product
—— A Pathway for Containment & Delivery Systems | | |
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| What you will learn - Review the FDA's final guidance of "Considerations in Demonstrating Interchangeability with a Reference Product" released in May 2019.
- The guidance includes specific requirements with respect to the "Presentation" meaning the containment and delivery systems for the biosimilar.
- Analytical Testing Considerations for Biosimilars and Interchangeability.
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| | Whitney Winters
Senior Director, Strategic Marketing West Biologics, Container Systems | | | | Janet Gaboury Senior Specialist in
Regulatory Affairs,
North America | | | | Jennifer Riter Senior Director, West Analytical Services and Business Operations | | |
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| | CPhI & P-MEC China E-trade Season
March - June 2021 | | |
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