The WHO-ISoP Pharmacovigilance Curriculum: 2026 Update
Abstract
This article presents a pharmacovigilance (PV) curriculum which was jointly developed by the World Health Organization (WHO) and the International Society of Pharmacovigilance (ISoP). It is an expanded update of a PV curriculum which WHO and ISoP developed in 2014 and responds to major scientific, technological, regulatory, social and public health developments that have reshaped PV over the last 12 years. Topics such as advanced therapies, global health emergencies, antimicrobial resistance, digital health, artificial intelligence, real-world evidence, medical device safety, the environmental impact of medicines, risk communication and patient engagement are addressed. The curriculum was developed through an international collaboration involving 82 contributors from different regions and professional backgrounds. The original three-level hierarchical structure was retained, with each chapter divided into four sections and each section into five or six subsections. The number of chapters increased from 15 to 26, the number of practical tasks from 40 to 125 and the number of references from 260 to 469. Practical tasks and references are provided as Electronic Supplementary Materials. The curriculum provides a comprehensive and structured inventory of contemporary PV and thus represents a reference that lecturers and institutions can use to develop context-specific training programmes. Its structure provides conceptual clarity while allowing adaptation to different settings, learners' roles and prior knowledge, local priorities, available time and resources. It is not intended to prescribe a single standardised course. Instead, it supports the development of introductory, advanced, comprehensive or topic-specific PV education programmes. The update reflects a shared commitment of the WHO and the ISoP to strengthening PV education and capacity across regulatory, academic, healthcare, public health and industrial settings in accordance with the recommendation of the 2026 World Health Assembly to strengthen PV.
Related
- Fluoropyrimidine-associated gastrointestinal toxicity: pharmacovigilance reporting signals and in vitro evidence of epithelial injury, barrier impairment, and inflammatory responses
- Curriculum unlearning in humans and neural networks
- Identifying DNA mutations in Sepia, White, Yellow, and Vestigial genes in D. melanogaster - Integrating inquiry-based experiential learning into undergraduate Genetics Laboratory curriculum
- Student satisfaction-oriented physical education teacher education curriculum: A framework for evaluating implementation effectiveness and optimizing quality
- ELiAH2: update of the atlas of E3 ligases in human tissues by integrating tissue-specificity and docking properties of ligands for targeted protein degradation
BibTeX
@article{beckmann2026whoisop,
title = {{The WHO-ISoP Pharmacovigilance Curriculum: 2026 Update}},
author = {Jürgen Beckmann and Marco Tuccori and Priya Bahri and Francesco Salvo and Mónica Tarapués and Manal M Younus and Hussain Al Ramimmy and Mayada Alkhakany and Thamir Alshammari and Beate Aurich and Nicole Baker and Madhava Balakrishnan and Ghita Benabdallah and Pernette Bourdillon Esteve and Ian Boyd and Siva Kumar Buddha and Gianmario Candore and Emiliano Cappello and Angela Caro-Rojas and Rebecca Chandler and Jerin Jose Cherian and Karen Cohen and Salvatore Crisafulli and Shelley Deeks and Jean-Christophe Delumeau and Moin Don and Joan Dsouza and Ernest D Dzidzornu and Brian D Edwards and I. Ralph Edwards and Jefman Efendi Marzuki Hy and Albert Figueras and Mohammed I Fouda and Ayako Fukushima and Giovanni Furlan and Georgy Genov and Gloria Giraldo and Michael Gold and Tarek Hammad and Kenneth Hartigan-Go and Maria Teresa Herdeiro and Richard Hill and Noha Iessa and Katarina Ilic and Sujeet Jain and Eunmi Kim and Larissa Kopp and Veronique Kugener and Smaragda Lamprianou and Navinisha Lee and Marie Lindquist and Michaela Lucas and Viola Macolic Sarinic and Ishak Mansi and Ushma C Mehta and Johanna C Meyer and Joseph Mitchell and Maryam Naeem and Comfort Ogar and Ladi Owolabi},
journal = {Drug Safety},
year = {2026},
month = sep,
doi = {10.1007/s40264-026-01717-y},
url = {https://hal.science/hal-05801763v1},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - The WHO-ISoP Pharmacovigilance Curriculum: 2026 Update
AU - Jürgen Beckmann
AU - Marco Tuccori
AU - Priya Bahri
AU - Francesco Salvo
AU - Mónica Tarapués
AU - Manal M Younus
AU - Hussain Al Ramimmy
AU - Mayada Alkhakany
AU - Thamir Alshammari
AU - Beate Aurich
AU - Nicole Baker
AU - Madhava Balakrishnan
AU - Ghita Benabdallah
AU - Pernette Bourdillon Esteve
AU - Ian Boyd
AU - Siva Kumar Buddha
AU - Gianmario Candore
AU - Emiliano Cappello
AU - Angela Caro-Rojas
AU - Rebecca Chandler
AU - Jerin Jose Cherian
AU - Karen Cohen
AU - Salvatore Crisafulli
AU - Shelley Deeks
AU - Jean-Christophe Delumeau
AU - Moin Don
AU - Joan Dsouza
AU - Ernest D Dzidzornu
AU - Brian D Edwards
AU - I. Ralph Edwards
AU - Jefman Efendi Marzuki Hy
AU - Albert Figueras
AU - Mohammed I Fouda
AU - Ayako Fukushima
AU - Giovanni Furlan
AU - Georgy Genov
AU - Gloria Giraldo
AU - Michael Gold
AU - Tarek Hammad
AU - Kenneth Hartigan-Go
AU - Maria Teresa Herdeiro
AU - Richard Hill
AU - Noha Iessa
AU - Katarina Ilic
AU - Sujeet Jain
AU - Eunmi Kim
AU - Larissa Kopp
AU - Veronique Kugener
AU - Smaragda Lamprianou
AU - Navinisha Lee
AU - Marie Lindquist
AU - Michaela Lucas
AU - Viola Macolic Sarinic
AU - Ishak Mansi
AU - Ushma C Mehta
AU - Johanna C Meyer
AU - Joseph Mitchell
AU - Maryam Naeem
AU - Comfort Ogar
AU - Ladi Owolabi
PY - 2026
DA - 2026/09/20
JO - Drug Safety
DO - 10.1007/s40264-026-01717-y
UR - https://hal.science/hal-05801763v1
AB - This article presents a pharmacovigilance (PV) curriculum which was jointly developed by the World Health Organization (WHO) and the International Society of Pharmacovigilance (ISoP). It is an expanded update of a PV curriculum which WHO and ISoP developed in 2014 and responds to major scientific, technological, regulatory, social and public health developments that have reshaped PV over the last 12 years. Topics such as advanced therapies, global health emergencies, antimicrobial resistance, digital health, artificial intelligence, real-world evidence, medical device safety, the environmental impact of medicines, risk communication and patient engagement are addressed. The curriculum was developed through an international collaboration involving 82 contributors from different regions and professional backgrounds. The original three-level hierarchical structure was retained, with each chapter divided into four sections and each section into five or six subsections. The number of chapters increased from 15 to 26, the number of practical tasks from 40 to 125 and the number of references from 260 to 469. Practical tasks and references are provided as Electronic Supplementary Materials. The curriculum provides a comprehensive and structured inventory of contemporary PV and thus represents a reference that lecturers and institutions can use to develop context-specific training programmes. Its structure provides conceptual clarity while allowing adaptation to different settings, learners' roles and prior knowledge, local priorities, available time and resources. It is not intended to prescribe a single standardised course. Instead, it supports the development of introductory, advanced, comprehensive or topic-specific PV education programmes. The update reflects a shared commitment of the WHO and the ISoP to strengthening PV education and capacity across regulatory, academic, healthcare, public health and industrial settings in accordance with the recommendation of the 2026 World Health Assembly to strengthen PV.
SN - 0114-5916
ER -