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Glossary

Risk-benefit balance

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An evaluation of the positive therapeutic effects of the medicinal product in relation to the risks, i.e. any risk relating to the quality, safety or efficacy of the medicinal product as regards patients’ health or public health. 

Other glossary definitions

P

Protocol Assistance (PA)

Protocol assistance is the special form of scientific advice available for companies developing designated orphan…

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P

Pharmacovigilance

Science and activities relating to the detection, assessment, understanding and prevention of adverse effects or…

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