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Glossary

Trend reporting

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A reporting type used by the manufacturer when a significant increase in events not normally considered to be incidents occurred and for which pre-defined trigger levels are used to determine the threshold for reporting. 

Other glossary definitions

P

Post-Authorization Safety Study (PASS)

A Post-Authorization Safety Study (PASS) is a study performed after the marketing authorization and aiming…

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G

Genetically modified organism (GMO)

Genetically modified organism (GMO) means an organism, with the exception of human beings, in which…

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