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.
Within the framework of the Grant Agreement between the European Commission and the EDQM/Council of Europe, a training course on biovigilance and on reporting of SARE in the field of tissues and cells will be organised.
The aim of this training course is 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 covers 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 that will be covered are:
- 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)
Preliminary programme (available soon)
The working language is English.
Dates and format
The course will take place from 13 September to 15 October 2021.
Live sessions will take place as follows, please save the dates in your calendars:
23 September 2021 from 14-16h
30 September 2021 from 14-16h
7 October 2021 from 14-16h
14 October 2021 from 14-16h
The course has been prepared by top European experts in the field and provides 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.
Who should attend?
This course will be 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).