Import Risks & Clinical Supply Depots

Overview


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A sponsor running a clinical trial in Israel arranged to ship their clinical trial product from Europe to a depot in Israel. With the protocol based in the US and the IMP approved in the EU, the sponsor incorrectly assumed and, without checking further requirements, that Israel had the same QP (qualified person) approval process as the EU.

Learn how Catalent was able to help the sponsor meet the QP requirements and start their study on time.

This content is provided by Catalent, and any views and opinions expressed do not necessarily reflect those of Outsourcing-Pharma.com

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