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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

I

ISO14155

International standard addressing good clinical practice for the design, conduct, recording and reporting of clinical…

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J

Justification Table

In relation to Policy 70, to be completed by the Applicant to justify the proposed…

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