Frontiers in Medicine | Regulatory Science

Review

Published on 05 Jun 2024

A decade of collaboration in medicines regulation: healthcare professionals engaging with the European Medicines Agency

in Regulatory Science

Ivana Silva
Giulia Gabrielli
Juan Garcia Burgos
Isabelle Moulon
Gonzalo Calvo Rojas
Ulrich Jaeger
Rosa Giuliani

Frontiers in Medicine

doi 10.3389/fmed.2024.1399947

3,284 views
3 citations

Review

Published on 03 Jun 2024

Artificial intelligence in healthcare: an Italian perspective on ethical and medico-legal implications

in Regulatory Science

Sara Sablone
Mara Bellino
Andrea Nicola Cardinale
Massimiliano Esposito
Francesco Sessa
Monica Salerno

Frontiers in Medicine

doi 10.3389/fmed.2024.1343456

5,568 views
16 citations

Review

Published on 03 Jun 2024

Navigating the challenges of clinical trial professionals in the healthcare sector

in Regulatory Science

Galo Peralta
Blanca Sánchez-Santiago

Frontiers in Medicine

doi 10.3389/fmed.2024.1400585

36,209 views
13 citations

Original Research

Published on 31 May 2024

International regulatory and publicly-funded initiatives to advance drug repurposing

in Regulatory Science

Eva Louise Spin
Aukje K. Mantel-Teeuwisse
Anna Maria Gerdina Pasmooij

Frontiers in Medicine

doi 10.3389/fmed.2024.1387517

3,095 views
7 citations

Original Research

Published on 30 May 2024

Current situation and issues regarding termination of risk management plans in Japan

in Regulatory Science

Natsuko Kameyama
Aoi Hosaka
Hideki Maeda

Frontiers in Medicine

doi 10.3389/fmed.2024.1387652

2,807 views
2 citations

Technology and Code

Published on 27 May 2024

Transforming evidence-based clinical guidelines into implementable clinical decision support services: the CAREPATH study for multimorbidity management

in Regulatory Science

Mert Gencturk
Gokce B. Laleci Erturkmen
A. Emre Akpinar
Omid Pournik
Bilal Ahmad
Theodoros N. Arvanitis
Wolfgang Schmidt-Barzynski
Tim Robbins
Ruben Alcantud Corcoles
Pedro Abizanda

Frontiers in Medicine

doi 10.3389/fmed.2024.1386689

6,743 views
6 citations

Review

Published on 23 May 2024

Leveraging patient experience data to guide medicines development, regulation, access decisions and clinical care in the EU

in Regulatory Science

Diogo Almeida
Denise Umuhire
Rosa Gonzalez-Quevedo
Ana António
Juan Garcia Burgos
Patrice Verpillat
Nathalie Bere
Bruno Sepodes
Carla Torre

Frontiers in Medicine

doi 10.3389/fmed.2024.1408636

9,280 views
13 citations

Mini Review

Published on 22 May 2024

Artificial intelligence in drug repurposing for rare diseases: a mini-review

in Regulatory Science

Lucas Cortial
Vincent Montero
Sébastien Tourlet
Joanie Del Bano
Olivier Blin

Frontiers in Medicine

doi 10.3389/fmed.2024.1404338

13,811 views
29 citations

Methods

Published on 16 May 2024

OHDSI-compliance: a set of document templates facilitating the implementation and operation of a software stack for real-world evidence generation

in Regulatory Science

Felix N. Wirth
Hammam Abu Attieh
Fabian Prasser

Frontiers in Medicine

doi 10.3389/fmed.2024.1378866

2,624 views

Original Research

Published on 15 May 2024

Artificial intelligence based data curation: enabling a patient-centric European health data space

in Regulatory Science

Isabelle de Zegher
Kerli Norak
Dominik Steiger
Heimo Müller
Dipak Kalra
Bart Scheenstra
Isabella Cina
Stefan Schulz
Kanimozhi Uma
Petros Kalendralis

Frontiers in Medicine

doi 10.3389/fmed.2024.1365501

10,460 views
8 citations

Mini Review

Published on 13 May 2024

Exploring regulatory flexibility to create novel incentives to optimize drug discovery

in Regulatory Science

Jacqueline A. Sullivan
E. Richard Gold

Frontiers in Medicine

doi 10.3389/fmed.2024.1379966

3,006 views
4 citations

Policy and Practice Reviews

Published on 09 May 2024

Cybersecurity policy framework requirements for the establishment of highly interoperable and interconnected health data spaces

in Regulatory Science

Christian Luidold
Christoph Jungbauer

Frontiers in Medicine

doi 10.3389/fmed.2024.1379852

6,272 views
10 citations

Methods

Published on 02 May 2024

Application of the Composite Quality Score (CQS-2B) versus Cochrane’s Risk of Bias tool (Version 2) in systematic reviews of clinical trials – an exploratory study

in Regulatory Science

Steffen Mickenautsch
Stefan Rupf
Veerasamy Yengopal

Frontiers in Medicine

doi 10.3389/fmed.2024.1307815

1,825 views

Brief Research Report

Published on 26 Apr 2024

Promoting opioids, a story about how to influence medical science and opinions

in Regulatory Science

Maud Bernisson
Sergio Sismondo

Frontiers in Medicine

doi 10.3389/fmed.2024.1327939

4,308 views
5 citations

Original Research

Published on 17 Apr 2024

The creation of an adaptable informed consent form for research purposes to overcome national and institutional bottlenecks in ethics review: experience from rare disease registries

in Regulatory Science

Annalisa Landi
Yanis Mimouni
Viviana Giannuzzi
Franz Schaefer
Annagrazia Altavilla
Spencer Gibson
Daria Julkowska

Frontiers in Medicine

doi 10.3389/fmed.2024.1384026

3,326 views
2 citations

Mini Review

Published on 12 Apr 2024

Synthetic polypeptides using a biologic as a reference medicinal product – the European landscape of regulatory approvals

in Regulatory Science

Kevin Klein
Jens Heisterberg
Pieter Stolk

Frontiers in Medicine

doi 10.3389/fmed.2024.1335928

5,961 views
2 citations

Perspective

Published on 11 Apr 2024

Perspectives on systematic capacity building in pharmaceutical regulation for regulators of medical products

in Regulatory Science

Luther Gwaza
Andrew Chemwolo
Mario Musonda
Rutendo Kuwana
Admire Dube

Frontiers in Medicine

doi 10.3389/fmed.2024.1394562

2,679 views
3 citations

Original Research

Published on 10 Apr 2024

Health data space nodes for privacy-preserving linkage of medical data to support collaborative secondary analyses

in Regulatory Science

Martin Baumgartner
Karl Kreiner
Aaron Lauschensky
Bernhard Jammerbund
Klaus Donsa
Dieter Hayn
Fabian Wiesmüller
Lea Demelius
Robert Modre-Osprian
Sabrina Neururer

Frontiers in Medicine

doi 10.3389/fmed.2024.1301660

6,541 views
8 citations

Original Research

Published on 05 Apr 2024

Identifying and costing common gaps in Central and West Africa pharmaceutical regulation

in Regulatory Science

Claudia P. Alfonso
Guy B. N’Jambong
Alaa Magdy
Laura Di Trapani
Rutendo Kuwana
Abraham G. Kahsay
Diadié Maïga
Sybil N. A. Ossei-Agyeman-Yeboah
Aimé B. Djitafo Fah
Margareth Ndomondo-Sigonda

Frontiers in Medicine

doi 10.3389/fmed.2024.1362253

5,874 views
4 citations

Policy Brief

Published on 02 Apr 2024

Declaration of Helsinki: ethical norm in pursuit of common global goals

in Regulatory Science

Chieko Kurihara
Sandor Kerpel-Fronius
Sander Becker
Anthony Chan
Yasmin Nagaty
Shehla Naseem
Johanna Schenk
Kotone Matsuyama
Varvara Baroutsou

Frontiers in Medicine

doi 10.3389/fmed.2024.1360653

11,626 views
30 citations

Original Research

Published on 28 Mar 2024

Innovative research methodologies in the EU regulatory framework: an analysis of EMA qualification procedures from a pediatric perspective

in Regulatory Science

Viviana Giannuzzi
Arianna Bertolani
Silvia Torretta
Giorgio Reggiardo
Eleonora Toich
Donato Bonifazi
Adriana Ceci

Frontiers in Medicine

doi 10.3389/fmed.2024.1369547

5,019 views
4 citations

Hypothesis and Theory

Published on 28 Mar 2024

Physician’s autonomy in the face of AI support: walking the ethical tightrope

in Regulatory Science

Florian Funer
Urban Wiesing

Frontiers in Medicine

doi 10.3389/fmed.2024.1324963

7,368 views
17 citations

Original Research

Published on 21 Mar 2024

Methodological biases in observational hospital studies of COVID-19 treatment effectiveness: pitfalls and potential

in Regulatory Science

Oksana Martinuka
Derek Hazard
Hamid Reza Marateb
Marjan Mansourian
Miguel Ángel Mañanas
Sergio Romero
Manuel Rubio-Rivas
Martin Wolkewitz

Frontiers in Medicine

doi 10.3389/fmed.2024.1362192

5,583 views
10 citations

Editorial

Published on 18 Mar 2024

Editorial: Current priorities in health research agendas: tensions between public and commercial interests in prioritizing biomedical, social, and environmental aspects of health

in Regulatory Science

Mercedes García Carrillo
Marc-André Gagnon
Matías Blaustein

Frontiers in Medicine

doi 10.3389/fmed.2024.1391982

2,032 views
4 citations

518 articles

articles

A decade of collaboration in medicines regulation: healthcare professionals engaging with the European Medicines Agency

Artificial intelligence in healthcare: an Italian perspective on ethical and medico-legal implications

Navigating the challenges of clinical trial professionals in the healthcare sector

International regulatory and publicly-funded initiatives to advance drug repurposing

Current situation and issues regarding termination of risk management plans in Japan

Transforming evidence-based clinical guidelines into implementable clinical decision support services: the CAREPATH study for multimorbidity management

Leveraging patient experience data to guide medicines development, regulation, access decisions and clinical care in the EU

Artificial intelligence in drug repurposing for rare diseases: a mini-review

OHDSI-compliance: a set of document templates facilitating the implementation and operation of a software stack for real-world evidence generation

Artificial intelligence based data curation: enabling a patient-centric European health data space

Exploring regulatory flexibility to create novel incentives to optimize drug discovery

Cybersecurity policy framework requirements for the establishment of highly interoperable and interconnected health data spaces

Application of the Composite Quality Score (CQS-2B) versus Cochrane’s Risk of Bias tool (Version 2) in systematic reviews of clinical trials – an exploratory study

Promoting opioids, a story about how to influence medical science and opinions

The creation of an adaptable informed consent form for research purposes to overcome national and institutional bottlenecks in ethics review: experience from rare disease registries

Synthetic polypeptides using a biologic as a reference medicinal product – the European landscape of regulatory approvals

Perspectives on systematic capacity building in pharmaceutical regulation for regulators of medical products

Health data space nodes for privacy-preserving linkage of medical data to support collaborative secondary analyses

Identifying and costing common gaps in Central and West Africa pharmaceutical regulation

Declaration of Helsinki: ethical norm in pursuit of common global goals

Innovative research methodologies in the EU regulatory framework: an analysis of EMA qualification procedures from a pediatric perspective

Physician’s autonomy in the face of AI support: walking the ethical tightrope

Methodological biases in observational hospital studies of COVID-19 treatment effectiveness: pitfalls and potential

Editorial: Current priorities in health research agendas: tensions between public and commercial interests in prioritizing biomedical, social, and environmental aspects of health