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POUR Repository Interactive Q&A Interactive Q&A session with MAH's on the new functionality provided in release 1.06.00Presented by Kristina Pulsar on 24 May 2016An agency of the European UnionOutline
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PSUR repository interactive Q&A is a platform where stakeholders can interact and ask questions related to Periodic Safety Update Reports (PSURs) of medicinal products.
Marketing authorization holders (MAHs) are required to file PSUR repository interactive Q&A for their medicinal products.
To fill out PSUR repository interactive Q&A, MAHs need to provide relevant information about the safety updates of their medicinal products.
The purpose of PSUR repository interactive Q&A is to ensure transparency and communication between stakeholders regarding the safety updates of medicinal products.
Information such as adverse reactions, new safety concerns, and risk minimization measures must be reported on PSUR repository interactive Q&A.
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