Dear all,
I am working on a product where the primary health authority may be SwissMedic rather than FDA or EMA. While a member of ICH, there is currently no immunogenicity guidance from ICH although of course M10 applies for bioanalytical. While we are planning to reference the EMA guidance for general strategy, I was wondering if anyone had direct experience with immunogenicity questions or expectations from SwissMedic that were different from the FDA and EMA guidance documents.
Thank you,
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Joleen White Ph.D.
AAPS 2022 Global Health Community Chair
AAPS 2022 Bioanalytical Community Past Chair
Bioassay Development Lead
Gates Medical Research Institute
Cambridge MA
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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