R & Y International 2nd Annual Medical Device Biocompatibility Conference
R & Y International 2nd Annual Medical Device Biocompatibility Conference
November 20-22 | Berlin, Germany
WuXi AppTec is proud to be presenting at the 2nd Annual Medical Device Biocompatibility Conference on November 20th, 2024 at the Novotel Berlin Mitte Hotel in Berlin Germany.
Presentations
Title: A Path to Approval-The Regulatory Journey of a Combination Product
Presenter: Sandi Schaible, Executive Director, Analytical Chemistry and Regulatory Toxicology, WuXi AppTec
Date/Time: Wednesday, November 20 at 11:40am CET
Presentation Abstract (for reference):
Title: A Path to Approval-The Regulatory Journey of a Combination Product
US Regulatory Approval is rarely smooth sailing for any medical product and for combination products the journey can be filled with unexpected detours if you are not properly prepared. Understanding the regulatory landscape before you develop your test plan can get you to your destination on time. We will walk through:
- Why understanding the primary mode of action is important
- How a presub meeting can set you on a clear path
- What are the differences between USP and ISO methods when it comes to Extractable/Leachable testing
- When to apply USP<1663>/USP<1664> and/or ISO 10993 parts 17 and 18 in your test plan
Finally, we will navigate a combination product case study and explore some of the hidden pitfalls encountered during the journey.
Date/Time: Wednesday, November 20 at 11:40am CET
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