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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

M

Misuse of a medicinal product

Situations where the medicinal product is intentionally and inappropriately used not in accordance with the…

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D

Data Protection Officer (DPO)

The primary role of the DPO is to ensure that his organization processes the personal…

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