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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

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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C

Comparability Protocol

A comprehensive, prospectively written plan for assessing the effect of a proposed CMC post-approval change…

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