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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

E

Environmental Risk Assessment (ERA)

In accordance with Article 8(3) of Directive 2001/83/EC, as amended, the evaluation of the potential…

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P

Prebiotic

Nonviable substance which, when administered in adequate amount, selectively promotes the growth, development and/or activity…

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