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A PostAuthorisation Safety Study (PASS) Protocol Title Drug Utilization Study of in Europe Using DatabasesProtocol version identifierVersion 2: 20 July 2016Date of last version of protocolVersion
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What is a post-authorisation safety study?
A post-authorisation safety study is a study conducted after a medicine has been authorised in order to further assess its safety profile.
Who is required to file a post-authorisation safety study?
The marketing authorisation holder is required to file a post-authorisation safety study.
How to fill out a post-authorisation safety study?
A post-authorisation safety study can be filled out by following the specific guidelines provided by regulatory authorities.
What is the purpose of a post-authorisation safety study?
The purpose of a post-authorisation safety study is to monitor the safety of a medicine in real-world usage.
What information must be reported on a post-authorisation safety study?
Information such as adverse reactions, patient outcomes, and any new safety concerns must be reported on a post-authorisation safety study.
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