Bahri, Priya
Pariente, Antoine
Article History
Accepted: 5 August 2021
First Online: 15 September 2021
Declarations
:
: No specific funding was received for the conduct of this study.
: Priya Bahri and Antoine Pariente have no conflicts of interests to declare. 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 Securité du Médicament et des Produits de Santé; 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.
: Not applicable.
: Not applicable.
: This study used the records described and referenced.
: Not applicable.
: 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 François Houÿez, EURORDIS, during personal conversations with the authors has been obtained.