The European Medicines Agency (EMA) is set to conduct a virtual live hands-on training course tailored for sponsors of clinical trials, focusing on the EudraVigilance system. Scheduled for December 2025, the event aims to enhance the capabilities of participants in managing and analyzing adverse reactions related to medicinal products within the European Economic Area (EEA).
Comprehensive Training Schedule
Spanning three consecutive days from December 8 to December 10, 2025, the training will be accessible online, allowing wide participation across different regions. Each session, conducted between 09:00 and 13:00 Amsterdam time (CET), will delve into the functionalities of EudraVigilance, the EU’s pivotal system for monitoring adverse drug reactions during both clinical trials and post-authorization phases.
Mandatory Reporting Standards
In alignment with the EMA Management Board’s directives, the course will emphasize the obligatory use of the ISO Individual Case Safety Report (ICSR) standard based on ICHE2B(R3) modalities, effective since June 30, 2022. Participants will also learn the required ISO standard terminology for pharmaceutical dose forms and routes of administration, essential for accurate and compliant reporting.
• Master the latest EudraVigilance reporting standards
• Ensure compliance with ISO ICSRs for accurate data submission
• Facilitate seamless registration and reporting processes with EMA support
Upon successful completion of the training and passing the knowledge evaluation, participants will receive a certification from the EMA. This credential is crucial for organizations intending to register their first user Responsible Person (RP) or utilize the EudraVigilance web application (EVWEB) for the electronic reporting of ICSRs, ensuring smooth integration with the EV production environment.
The training not only equips sponsors with the necessary technical skills but also reinforces the importance of vigilant pharmacovigilance practices in safeguarding public health. By participating, organizations can streamline their reporting mechanisms, thereby contributing to the overall efficacy and safety of medicinal products in the market.
Ensuring accurate and timely reporting of adverse reactions is paramount for maintaining the integrity of clinical trials and post-market surveillance. The EMA’s initiative reflects a proactive approach to enhancing regulatory compliance and fostering a robust pharmacovigilance culture among clinical trial sponsors.
Participants are encouraged to register promptly as slots are limited. Comprehensive course materials and agendas are available for download, providing prospective attendees with detailed insights into the training modules and schedule. Engaging in this training will not only fulfill regulatory requirements but also empower sponsors with the expertise to effectively utilize the EudraVigilance system, ultimately contributing to safer and more reliable medicinal products for the European market.
This article has been prepared with the assistance of AI and reviewed by an editor. For more details, please refer to our Terms and Conditions. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author.
