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Policy and Practice Reviews

Accepted on 07 Oct 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 Guignard
Flor M Munoz
Eileen Dareng
Kourtney Davis
Marina Amaral de Avila Machado
Shahar Shmuel
Laura Taddei
Lydie Marcelon

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1648854

248 views

Perspective

Accepted on 03 Oct 2025

The Role of MedDRA in Global Pharmacovigilance and Public Health during COVID-19: Pandemic Preparedness and Response

in Vaccine Safety and Regulation

Brian O’Hare
Heba Ibrahim
Patrick Revelle

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1607642

146 views

Perspective

Published on 15 Aug 2025

A national pharmacovigilance centre perspective on pandemic preparedness - lessons learned from the COVID-19 pandemic

in Vaccine Safety and Regulation

Florence van Hunsel
Agnes Kant

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1644680

2,878 views

Original Research

Published on 12 Aug 2024

Cohort event monitoring of safety of COVID-19 vaccines: the Italian experience of the “ilmiovaccinoCOVID19 collaborating group”

in Vaccine Safety and Regulation

Nicoletta Luxi
Chiara Bellitto
Francesco Ciccimarra
Emiliano Cappello
Luca L’Abbate
Marco Bonaso
Chiara Ajolfi
Paolo Baldo
Roberto Bonaiuti
Claudio Costantino

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1363086

2,786 views

Systematic Review

Published on 31 Jan 2024

Menstrual disorders following COVID-19 vaccination: a review using a systematic search

in Vaccine Safety and Regulation

Veerle R. Smaardijk
Rana Jajou
Agnes Kant
Florence P. A. M. van Hunsel

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1338466

32,879 views
9 citations