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Glossary

Data lock point (DLP)

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For a periodic safety update report (PSUR), the date designated as the cut-off date for data to be included in a PSUR.  

For a periodic benefit-risk evaluation report (PBRER), the date designated as the cut-off date for data to be included in a PBRER, based on the international birth date.  

For a development safety update report (DSUR), the date designated as the cut-off date for data to be included in a DSUR, based on the development international birth date.  

Other glossary definitions

M

Medical Device Software

A “medical device software”, refers to a computer application that meets the legal definition of…

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C

Company Core Data Sheet (CCDS)

A document prepared by the marketing authorization holder containing, in addition to safety information, material…

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