Authors
Jürgen Beckmann, Marco Tuccori, Priya Bahri, Francesco Salvo, Mónica Tarapués, Manal M Younus, Hussain Al Ramimmy, Mayada Alkhakany, Thamir Alshammari, Beate Aurich, Nicole Baker, Madhava Balakrishnan, Ghita Benabdallah, Pernette Bourdillon Esteve, Ian Boyd, Siva Kumar Buddha, Gianmario Candore, Emiliano Cappello, Angela Caro-Rojas, Rebecca Chandler, Jerin Jose Cherian, Karen Cohen, Salvatore Crisafulli, Shelley Deeks, Jean-Christophe Delumeau, Moin Don, Joan Dsouza, Ernest D Dzidzornu, Brian D Edwards, I Ralph Edwards, Jefman Efendi Marzuki Hy, Albert Figueras, Mohammed I Fouda, Ayako Fukushima, Giovanni Furlan, Georgy Genov, Gloria Giraldo, Michael Gold, Tarek Hammad, Kenneth Hartigan-Go, Maria Teresa Herdeiro, Richard Hill, Noha Iessa, Katarina Ilic, Sujeet Jain, EunMi Kim, Larissa Kopp, Veronique Kugener, Smaragda Lamprianou, Navinisha Lee, Marie Lindquist, Michaela Lucas, Viola Macolic Sarinic, Ishak Mansi, Ushma C Mehta, Johanna C Meyer, Joseph Mitchell, Maryam Naeem, Comfort Ogar, Ladi Owolabi, Jayesh Pandit, Lembit Rägo, Emanuel Raschi, Hadir Rostom, Mulugeta Russom, George T Sabblah, Maribel Salas, Souad Skalli, Fumihito Takanashi, Michael Tatley, Gianluca Trifiro, Claudia Vaca, Florence van Hunsel, Eugène van Puijenbroek, Jessica Liliana Vargas-Neri, Ryan J Walker, Xinyu Weng, Ian C K Wong, Qun-Ying Yue, Li Zhang, Omar Aimer, Shanthi N Pal
Published in
Drug safety. Sep 20, 2026. Epub Sep 20, 2026.
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.
PMID:
42763845
Bibliographic data and abstract were imported from PubMed on 21 Sep 2026.
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