Document 05.06
NMVO Alert Working Group
- Map national guidelines,
EMVS
similarities and reasons for
and
EMVS
differences
- Map demands from NCAs
European Alert
Management
- Evolve existing EMVO guidelines
System
- Specifications
- Development process
Ongoing processes for improving the system
Core functionalities of a European Alert Management System
Stabilisation
Automatic determination of the root causes of alerts, so
Preventative actions to reduce false alerts
targeted measures can be put in place.
Alert convergence
Enable a two-way communication conduit between the
Improved governance of the EMVS as ONE system
OBP and end-user (without actual y disclosing who the
end-user is)
Members
Swedish NMVO
EFPIA
Czech NMVO
PGEU
Lithuanian NMVO
EAHP
German NMVO
GIRP
Malta NMVO
GIRP
Netherlands NMVO
MfE
EMVO
EAHP/HOPE
EMVO
EAEPC
EMVO
EAEPC
stabilisation
alerts have reached an expected level
European Alert Management System
Outline a broad plan and define first actions.
Alert management by each NMVO. Improve by more sharing of best practices and next practices.
Alert harmonisation/convergence by EMVO
Already ongoing
Could ease and improve alert investigation
for OBPs (Based on the presentation from
QA.
MAH at last NMVO PM meeting.)
Map alert guidelines for al NMVOs
GAP analysis and
Differences and similarities explained.
Towards an European
Update of EMVO
standard alert
and demands from NCAs
comparison EMVO
Dialogue with NCAs/COM.
guidelines
management
guidelines
Input for update of EMVO guidelines.
Input for Case mapping.
Questionnaire sent out
Stakeholder input/expectations on
Each EMVO stakeholder to provide input on their
EAMS
expectations on Alert mngt system.
Like the EFPIA document. Input for Case mapping
Output: What use cases do the EAMS need to
Use Case /scenario mapping
support? Automatic alert mngt? What cases
should be handled by procedures not in the
system?
Preparation of Technical specifications
Technical specification
Design and implementation
Timelines first step
Who
December
January
February
Working group
Questionnaire sent out
F2F 13th January:
Get NCA input on draft of
Skype cal 12th December:
Analyse results/data
scope
formulating hypothesises for
Drafting scope of EAMS with
Get QA input on scope
testing with broader audience
EMVO
Present FMD workshop
final draft scope
EMVO
Preparation of Technical
Preparation of Technical
Present draft technical
Specifications of EAMS
Specifications of EAMS
specification of EAMS for
Desk research of NCA
feedback
timelines
Stakeholders
Supply WG with data
Validate hypothesis in
(questionnaire)
draft scope
Ask stakeholders for
expectations (EFPIA plan)
Questions?