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The presented work emerged from reflections and reviews conducted at EMA to inform ongoing work of the PRAC Interest Group on Measuring the Impact of Pharmacovigilance Activities. Antoine Pariente declares his role as an independent expert towards the French Medicines Agency (Agence Nationale de Securit\u00e9 du M\u00e9dicament et des Produits de Sant\u00e9; ANSM) and EMA. He coordinates the DRUGS Systematised Assessment in real-liFe Environment (DRUGS-SAFE) programme funded by the ANSM, which aims at providing an integrated system allowing the concomitant monitoring of medicines use and safety in France.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest"}},{"value":"Not applicable.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Not applicable.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"This study used the records described and referenced.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"Not applicable.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"The concept for the manuscript was proposed and the study conducted by PB in consultation with the PRAC Interest Group on Measuring the Impact of Pharmacovigilance Activities. As Chair of the PRAC Interest Group, AP conducted a critical review of the study analysis and results. Both PB and AP finalised the manuscript, approved it prior to submission to <i>Drug Safety<\/i>, and approved the final version for publication.<b>Consent to publish<\/b>Consent to publish statements made by Fran\u00e7ois Hou\u00ffez, EURORDIS, during personal conversations with the authors has been obtained.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}}]}}