WC500185968

EudraVigilance data analysis system. The focus of the review will be on the selection of a
disproportionality method, the thresholds for defining signals of disproportionate reporting (SDR) and
stratification and subgroup analysis. The draft revised guideline will be circulated to the PRAC in April
2015. It was agreed to run a pilot on the electronic Reaction Monitoring Reports (eRMRs) in the next
five months to collect information on the proposed changes. The draft revised guideline will be then
circulated to the PRAC for comments prior to release for public consultation.
12.5. Adverse Drug Reactions reporting and additional reporting
12.5.1. Management and Reporting of Adverse Reactions to Medicinal Products
None
12.5.2. Additional Monitoring
None
12.5.3. List of Products under Additional Monitoring
Consultation on the draft list, version March 2015
The PRAC was informed of the updates made to the list of products under additional monitoring.
Post-meeting note: The updated additional monitoring list was published on 25/03/2015 on the EMA
website (see: Home>Human Regulatory>Human medicines>Pharmacovigilance>Signal
management>List of medicines under additional monitoring)
12.6. EudraVigilance Database
12.6.1. Activities related to the confirmation of full functionality
12.6.1.1. EudraVigilance: revised business requirements
The EMA Secretariat presented the revised EudraVigilance business requirements. A set of detailed
business requirements related to EudraVigilance functionalities, more specifically in relation to the
EudraVigilance Data Analysis System (EVDAS), electronic Reaction Monitoring Reports (eRMRs) and the
public ADR website were prepared and reviewed by the Project and Maintenance Group 1 in
consultation with the EudraVigilance Expert Working Group (EV-EWG). The detailed requirements were
circulated to the Signal Management Review Technical (SMART) Working Group – Work Stream 1 - in
advance of their March 2015 meeting and also to the PRAC for consultation. Members were invited to
provide comments in writing until 31/03/2015.
12.6.1.2. Individual Case Safety Report (ICSR): revised form
The EMA Secretariat presented the revised individual case safety report (ICSR) form. The current
Council for International Organizations of Medical Sciences (CIOMS) I form had to be updated to
incorporate the new structure and data fields for ICH-E2B(R3) ICSRs. EMA drafted a new form based
on the R3 fields at the end of 2014. The objective of the form is to support the review of individual
cases for the purpose of signal detection, validation, confirmation and evaluation. This draft form was
discussed at the joint EudraVigilance Expert Working Group and Project and Maintenance Group 1
workshop in December 2014, followed by a consultation with EV-EWG, Project and Maintenance Group
1 and the EMA Signal Management Group. Following the consultation a revised report was presented to
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/257790/2015 Page 57/89