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Master Thesis

L’évaluation du rapport bénéfice/risque dans la nouvelle législation européenne concernant la pharmacovigilance : exemple de la dompéridone

Abstract : The evolution of the economic and social contexts led to the strong collaboration between the member states of the European union, particularly since the first of January, 1995, when the European Medicines Agency was created. In 2005 and in order to strengthen the monitoring of the risks of human medicines, the European commission decided to review the European system of pharmacovigilance. The new European pharmacovigilance legislation emerged in 2010. Furthermore, the benefit/risk balance of medicines continuously evolves regarding the new available information. The new European pharmacovigilance legislation introduced this concept and therefore, updated the assessment of the benefit/risk balance of medicines in order to prevent their adverse effects. My work enables to analyze the impact of this update regarding the assessment of the benefit/risk balance of medicines when authorized in European union, whatever the European authorisation procedure. The example of the referral triggered on the first of March, 2013 in order to assess the benefit/risk balance of domperidone-containing medicines was considered. It showed that the assessment of benefit/risk balance remains necessary through the life cycle of medicines.
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Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-01137666
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Submitted on : Tuesday, March 31, 2015 - 10:43:59 AM
Last modification on : Tuesday, May 11, 2021 - 11:36:18 AM
Long-term archiving on: : Wednesday, July 1, 2015 - 11:43:09 AM

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  • HAL Id : dumas-01137666, version 1

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Lucie Blanc. L’évaluation du rapport bénéfice/risque dans la nouvelle législation européenne concernant la pharmacovigilance : exemple de la dompéridone. Sciences pharmaceutiques. 2015. ⟨dumas-01137666⟩

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