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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

Real World Data (RWD)

An umbrella term for data regarding the effects of health interventions (e.g. safety, effectiveness, resource…

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I

Identified risk

An untoward occurrence for which there is adequate evidence of an association with the medicinal…

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