The WHO Pharmacovigilance (PVG) Team, in collaboration with the Paul-Ehrlich-Institut (PEI, Germany), held a hands-on RMP and PSUR Assessment Workshop for the Uganda National Drug Authority (NDA) from 10–12 November 2025 in Kampala.

The workshop strengthened NDA’s capacity to review Risk Management Plans (RMPs) and Periodic Safety Update Reports (PSURs) using the WHO Model Assessment Tools, focusing on safety specifications, pharmacovigilance planning, and risk-minimization measures for high-priority vaccines and medicines.

The 43rd Annual Meeting of the members of the WHO Programme for International Drug Monitoring (PIDM) was held in Cairo, Egypt (27-29 Oct 2025) with the theme ‘Pharmacovigilance in women of childbearing potential and children’.

Participants from around the world discussed this theme in the context of the WHO Global Smart Pharmacovigilance Strategy.

The World Health Organization Pharmacovigilance Team (WHO-PVG), in collaboration with the Uppsala Monitoring Centre (UMC), Sweden, facilitated a national workshop on VigiMobile introduction, a Smart-phone application tools for reporting Adverse Events Following Immunization (AEFI) and Adverse Drug Reactions (ADR) at Asmara, Eritrea on14–15 October 2025. The training brought together over 60 participants, including national and zonal pharmacovigilance focal points, regulatory affairs officers, representatives from the Expanded Programme on Immunization, and specialists in Information and Communication Technology. VigiMobile will enable the transition from paper-based reporting to a streamlined, digital system, thereby enhancing the efficiency, accuracy, and timeliness of adverse events reporting in the country.

The WHO Pharmacovigilance team (PVG), in close collaboration with the Paul-Ehrlich-Institut (PEI), Germany, hosted a workshop on Risk Management Plan (RMP) Assessment at WHO headquarters, Geneva, from 3 to 4 June 2025. Assessors from four African National Regulatory Authorities representing the departments of product registration and pharmacovigilance from Ghana, Rwanda, Sierra Leone and Zimbabwe participated.

The workshop introduced the Model RMP Assessment Tools developed by WHO PVG and provided an opportunity to pilot these and receive feedback from the countries based on their practical application, with the goal of refining and finalizing the tools.

The WHO Pharmacovigilance Team, in collaboration with the Uppsala Monitoring Centre, Sweden, facilitated a national training on the VigiFlow and VigiMobile tools on 22-23 May 2025 for over 50 vaccine safety focal points at Entebbe, Uganda. Participants included representatives from the Uganda National Regulatory Authority, Immunization Program, regional referral hospitals, and the WHO Country Office.

This training marks another significant milestone in WHO’s ongoing efforts to support low- and middle-income countries in strengthening electronic reporting of vaccine safety events. The adoption of these tools enables more efficient, accurate, and timely data capture and transmission from the field to national systems. It also ensures that critical safety data are simultaneously accessible to both national regulators and immunization programs.

Moreover, the improved speed and accuracy of data flow contribute to faster submission of safety information to the WHO global safety database, reinforcing global pharmacovigilance efforts.

The WHO Pharmacovigilance team strives to ensure safer use of medicines and vaccines throughout the life cycle of the products. We produce reliable, balanced information on the benefits and risks of medicines and vaccines, which enhances people’s care and safety.

Team Lead: Dr Shanthi Pal