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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

F

Falsified Medicinal Product

Any medicinal product with a false representation of (a) its identity, including its packaging and…

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S

Scientific Advice

Advice given by a regulatory/ reimbursement authority to a manufacturer on appropriate tests and studies…

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