2022
DOI: 10.1111/rego.12466
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Expert network interaction in the European Medicines Agency

Abstract: The need for supranational regulatory capacity and the drive for governmental control are two colliding forces in international governance. As a solution to this governance dilemma, European administrative networks need to simultaneously fulfill the demand for supranational institutions and maintain governmental control. The assessment of risks associated with medicines authorized on the European market is carried out by such a network of national regulators as part of the European Medicines Agency. To uncover… Show more

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Cited by 10 publications
(6 citation statements)
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“…EMA's safety committee, too, had a role to play and defend in public. The Pharmacovigilance Risk Assessment Committee (PRAC) became central in the vaccine reviewing processes of the AstraZeneca COVID‐19 vaccine (Schrama, 2022 ; Schrama et al, 2022 ). Potential risks of the vaccine were brought up after some instances of rare blood clotting.…”
Section: Horizontal Institutional Dynamicsmentioning
confidence: 99%
“…EMA's safety committee, too, had a role to play and defend in public. The Pharmacovigilance Risk Assessment Committee (PRAC) became central in the vaccine reviewing processes of the AstraZeneca COVID‐19 vaccine (Schrama, 2022 ; Schrama et al, 2022 ). Potential risks of the vaccine were brought up after some instances of rare blood clotting.…”
Section: Horizontal Institutional Dynamicsmentioning
confidence: 99%
“…One of the major challenges in implementing this multilateral project is the tension between national and supranational goals and targets for regulatory control (Schrama, 2023). To attenuate potential barriers, AU's project expounding the notion of pan-African solidarity and cooperation attributed the coordination of these regulatory networks to five of Africa's regional economic communities (RECs).…”
Section: Discussionmentioning
confidence: 99%
“…Who participates depends on the empirical context under investigation, but the professional status of actors is often explicitly stated or at least implied (Christensen, 2021;Kortendiek, 2020;Morgan, 2000;Schrama, 2022). But participation is no longer limited to corporate and technical professions and may also include other professionalised stakeholders including non-governmental organisations and academics (Christensen, 2021;Henriksen and Seabrooke, 2021).…”
Section: Legitimising Policy Outcomes Through Diverse Participationmentioning
confidence: 99%