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Glossary

Genetically modified organism (GMO)

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Genetically modified organism (GMO) means an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination.

 

Other glossary definitions

U

Unanticipated Serious Adverse Device Effect (USADE)

A Serious Adverse Device Effect which by its nature, incidence, severity, or outcome has not…

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R

Risk Management Plan (RMP)

A detailed description of the set of pharmacovigilance activities and interventions designed to identify, characterise,…

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