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Glossary

Safety concern

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An important identified risk, an important potential risk, or important missing information.

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Vigilance

From pre-market product safety to post-market surveillance, we provide integrated vigilance services…
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Clinical Safety Management

Multi-disciplinary approach to identify, assess and minimize the risks​ Clinical safety management is…

Other glossary definitions

U

Unanticipated death or unanticipated serious injury

A death or serious injury is considered unanticipated if the condition leading to the event was…

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P

Parallel Distribution

The distribution of a medicine from one Member State to another by a pharmaceutical company…

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