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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

R

Reference safety information

In periodic benefit-risk evaluation reports for medicinal products, all relevant safety information contained in the…

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L

Listedness

An Adverse Event is considered “listed” if it is described in the product’s Company Core…

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