Identifying regulatory outcomes of Non-interventional Post-Authorisation Safety Studies (PASS) in the European repository of studies using publicly available information

BackgroundPost-Authorisation Safety Studies (PASS) generate evidence that may support regulators to evaluate the benefit-risk profile of medicinal products and to take regulatory actions when needed. The European Medicine Agency (EMA) promoted decision-making transparency by publishing regulatory gu...

Ful tanımlama

Detaylı Bibliyografya

Asıl Yazarlar:	M. F. Almas, A. Girardi, S. Crisafulli, K. Gvozdanovic, K. M. Hakkarainen, G. Hyeraci, W. E. Hoogendoorn, B. Rillmann, G. Roberto, G. Vitturi, G. Trifirò, ENCePP WG3
Materyal Türü:	Artigo
Dil:	Inglês
Baskı/Yayın Bilgisi:	Frontiers Media S.A. 2025-09-01
Seri Bilgileri:	Frontiers in Drug Safety and Regulation
Konular:	post-authorisation safety studies (PASS) regulatory outcomes European Medicines Agency transparency risk management EU PAS register
Online Erişim:	https://www.frontiersin.org/articles/10.3389/fdsfr.2025.1574430/full
Etiketler:	Etiketle Etiket eklenmemiş, İlk siz ekleyin!