Post Authorisation | List of Frontiers open access articles

Review

Published on 04 Aug 2022

Contribution of patient registries to regulatory decision making on rare diseases medicinal products in Europe

in Drugs Outcomes Research and Policies

Carla J. Jonker
Elisabeth Bakker
Xavier Kurz
Kelly Plueschke

Frontiers in Pharmacology

doi 10.3389/fphar.2022.924648

16,477 views
28 citations

Original Research

Published on 23 Mar 2021

TuberOus SClerosis registry to increAse disease awareness (TOSCA) Post-Authorisation Safety Study of Everolimus in Patients With Tuberous Sclerosis Complex

in Pediatric Neurology

J. Chris Kingswood
Elena Belousova
Mirjana P. Benedik
Klemens Budde
Tom Carter
Vincent Cottin
Paolo Curatolo
Maria Dahlin
Lisa D'Amato
Guillaume B. d'Augères

Frontiers in Neurology

doi 10.3389/fneur.2021.630378

6,711 views
19 citations

Original Research

Published on 08 Feb 2024

Predicting the submission frequency of periodic safety update reports: development and application of the EURD tool

in Regulatory Science

María Gordillo-Marañón
Gianmario Candore
Marta López-Fauqued
Katerina-Christina Deli
Loris Piccolo
Paolo Alcini
Tom Paternoster-Howe
Irene Rager
Robin Ruepp
Menno van der Elst

Frontiers in Medicine

doi 10.3389/fmed.2024.1299190

5,357 views
1 citation

Review

Published on 23 Aug 2017

Adaptive Pathways: Possible Next Steps for Payers in Preparation for Their Potential Implementation

in Drugs Outcomes Research and Policies

Patricia Vella Bonanno
Michael Ermisch
Brian Godman
Antony P. Martin
Jesper Van Den Bergh
Liudmila Bezmelnitsyna
Anna Bucsics
Francis Arickx
Alexander Bybau
Tomasz Bochenek

Frontiers in Pharmacology

doi 10.3389/fphar.2017.00497

17,167 views
40 citations

Original Research

Published on 10 Sep 2025

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

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

M. F. Almas
A. Girardi
S. Crisafulli
K. Gvozdanovic
K. M. Hakkarainen
G. Hyeraci
W. E. Hoogendoorn
B. Rillmann
G. Roberto
G. Vitturi

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1574430

2,470 views

Policy and Practice Reviews

Published on 26 Nov 2025

Post-approval safety studies of vaccines in pregnancy: available regulatory guidance and next steps towards the more efficient generation of safety evidence

in Vaccine Safety and Regulation

Sarah C. MacDonald
Adrienne P. Guignard
Flor M. Munoz
Eileen O. Dareng
Kourtney J. Davis
Marina Amaral de Avila Machado
Shahar Shmuel
Laura Taddei
Lydie Marcelon

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1648854

1,708 views

Original Research

Published on 17 Nov 2023

Immuno-inflammatory in vitro hepatotoxicity models to assess side effects of biologicals exemplified by aldesleukin

in Cancer Immunity and Immunotherapy

Luise A. Roser
Sonja Luckhardt
Nicole Ziegler
Dominique Thomas
Pia Viktoria Wagner
Georg Damm
Andrea Scheffschick
Philip Hewitt
Michael J. Parnham
Susanne Schiffmann

Frontiers in Immunology

doi 10.3389/fimmu.2023.1275368

6,761 views
10 citations

Articles

Contribution of patient registries to regulatory decision making on rare diseases medicinal products in Europe

TuberOus SClerosis registry to increAse disease awareness (TOSCA) Post-Authorisation Safety Study of Everolimus in Patients With Tuberous Sclerosis Complex

Predicting the submission frequency of periodic safety update reports: development and application of the EURD tool

Adaptive Pathways: Possible Next Steps for Payers in Preparation for Their Potential Implementation

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

Post-approval safety studies of vaccines in pregnancy: available regulatory guidance and next steps towards the more efficient generation of safety evidence

Immuno-inflammatory in vitro hepatotoxicity models to assess side effects of biologicals exemplified by aldesleukin