According to EU Directive 2006/86/EC, EU Member States shall submit to the European Commission an annual report on the notification of Serious Adverse Reactions and Events (SARE) received by the Competent Authorities. This activity, commonly known as “the SARE exercise”, has been performed since 2010. However, different national reporting systems and interpretations of the reporting criteria have had an impact on the quality and accuracy of the reported data and, thus, on the interpretation of the results.
The aim of this training course was to help improve the mandatory EU SARE exercise by addressing the knowledge gaps detected in past exercises and contributing to the harmonisation of reporting practices. The course covered the fundamental aspects of biovigilance in the field of tissues and cells and provides guidance on how to ensure accurate and harmonised information is submitted to the annual EU SARE exercise.
The main topics covered were:
- How to perform the assessment of serious adverse reactions: severity, imputability or causes, probability of recurrence, consequences and impact in the recipient
- Assessment of serious adverse events
- Differences between serious and non-serious adverse events and reactions
- How to communicate risk to patients
- Rapid alerts
- European and international biovigilance projects (Notify Project, EU Vigilance Expert Subgroup)
Download the programme
The course was prepared by top European experts in the field and it provided participants with the opportunity to build knowledge and competencies by combining online weekly lectures (pre-recorded for participants to watch at their own pace) and active participation in online, live workshops and debates.
Reading Material
- Advisory Board Members
- Survival Kit for national vigilance officers for the assessment SAR & SAE (tissues and cells) reportable during the EU annual exercise
Target audience
This course was of interest to biovigilance officers involved in the EU SARE exercise through data reporting and/or data analysis in the fields of replacement tissues, haematopoietic progenitor cells (HPC) and/or medically assisted reproduction (MAR).
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