EU Rapid Alert Platform_Imad Sandid

EU Rapid Alert Platform_Imad Sandid
EU RAPID ALERT PLATFORM
Multi-Country Workshop on Increasing Blood
Availability and Providing the Highest Donor and
Patient Safety in Transfusion Therapy in
Emergency Special Circumstances _7-9 July
2014
Dr Imad SANDID
French National Agency for Medicines and Health Products Safety (ANSM)
Biological Products Department
Blood Components Team
QUICK ALERTS
Why quick alerts?
Article 9 of Directive 2005/61/EC: “Member States shall ensure
that their competent authorities communicate to each other such
information as is appropriate with regard to serious adverse
reactions and events in order to guarantee that blood or blood
components known or suspected to be defective are withdrawn
from use and discarded.
 Annex II Dir 2004/33/EC: Communicable diseases
 Annex 2.3 Dir 2004/33/EC: Notification of deferrals to the
Commission « with a view to Community action »
 Scope of the quick alerts:
 Product defects
 Threats to health/blood donations
 Approach developed for tissues and cells too

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QUICK ALERTS BLOOD
Ex. of quick alerts








Chikungunya
West Nile Virus
Dengue
Q fever
Trima Accel Automated Blood Collection System
Ortho Biovue System Cassettes
Macopharma Blood Bags
RadSure (irradiation indicator)
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QUICK ALERTS
Questions to address

Protocol for triggering/dissemination?
 Quick alerts vs. Information sharing
 Information exchange channels

Preventive measures?
 In the country directly concerned
 In the countries potentially threatened
 Epidemiological/risk assessment

Follow up?
 Closure of the alerts
 Preparation for likely outbreaks
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QUICK ALERTS
Development steps

2006-2010:
Communication
by
representatives of NCAs and MS)

2010-2012: CIRCA-CAs and CIRCA-QuickAlerts Blood: sharing
all documents in relation of meetings of CAs and other relevant
informations, and managing the quick alerts

Since
January
2013:
CIRCA-BC
Information Resource Centre
Businesses and Citizens).

e-mail
(mailinglist
of
(Communication
for
and
Administrations,
Since February 2014: RAB: Rapid Alerts platform for blood
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RAPID ALERTS PLATFORM
AGENDA
1. Introduction
2. RAB presentation – Version 1.0
3. RAB data protection
4. RAB Support
5. RAB Standard Operating Procedures
6. Hands-on
7. Next steps
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INTRODUCTION (1)
•
•
•
The scope of the Rapid Alert system for human blood and blood
components (RAB) is to provide the competent authorities of the European
Union (EU) and European Economic Area (EEA) countries and the
European Commission with an effective and secure network tool for the
exchange of information on urgent measures, to ensure the safety of
human blood and blood components for transfusion.
This rapid exchange of information allows all the Member States to verify
immediately whether they are affected by a problem initially raised and for
which a precautionary/corrective measure should be implemented.
The system includes:
• An "administration" module available for restricted list of users within
the official list of Competent Authorities (CA) and members of the
European Commission (EC) in order to create, follow-up and consult
alerts and final reports on tissues and cells.
• An alert form and notification process
• A set of notifications/reminders (based on deadlines and specific
events)
• A search functionality
• An easy to use and user friendly interface
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INTRODUCTION (2)
• Article 9 of the Directive 2005/61/EC regarding communication of
information between competent authorities and to the Commission
provides for the Member States to
• "ensure that their competent authorities communicate to each other
such information as is appropriate with regard to serious adverse
reactions and events in order to guarantee that blood or blood
components known or suspected to be defective are withdrawn from
use and discarded."
• This procedure does NOT replace the existing national procedures
by competent authorities of Member States for communicating the
information to the relevant parties in their own national healthcare
system.
• This procedure is NOT applicable for human or veterinary
medicinal products, human tissues and cells, organs or medical
devices.
• However, where precautionary/corrective actions taken are relevant for
these other sectors, an exchange of information should be ensured with
the national and European regulatory authorities responsible for these
sectors.
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RAB PRESNETATION – V1.0
1. Key stakeholders and user roles
2. Registration process
3. Alerts workflow
4. Main system features – Alert and Final Report
5. Notifications/reminders
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KEY STAKEHOLDERS
 Main stakeholders
 CA (Competent authorities) [28 Member States,
 +/- 50 Competent Authorities]
 EC (Unit D4 - Substances of human origin and
Tobacco control)
 Other stakeholders
All the other
stakeholders
will have only a
read access.
Some
information like
CA initiator
person detail,…
will not be
visible.
 European Medicine Agency
 European Centre for Disease Control
 EWRS contact points
 EC - other SANCO units:
- B2 Medical devices

- C3 Health threats

- D6 Pharmaceuticals
 World Health Organisation
 Other SoHO Network (Tissues & Cells, Organs)

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USER ROLES
1.
CA (Competent authorities)
1. CA initiator
1.
Create new alert
2.
Update the alert content
3.
Notify other CA and other stakeholders
4.
Choose the reporter CA (in the list of notified CA) who will write the final
report
2. CA notified
1.
Comments an alert for which it has been notified
2.
Forward the alert to another not yet notified CA
3.
Approve or reject the final report
CA Notified
- CA ‘affected’
1. Comment the final report
CA Affected
3. CA reporter (supervisor)
1.
Complete the final report
2.
Submit the final report for comment to all the affected CA
3.
Close the alert
2.
EC (European Commission) - Administrator role
1.
Validation of the user access
2.
Management of the reference list / Library
3.
Follow-up of dedicated functional mailbox
4.
Create an alert (as Initiator) Agence nationale de sécurité du médicament et des produits de santé
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REGISTRATION PROCESS
•
Via the official authentication system used by European
Commission (ECAS) and getting authorisation via SAAS.
•
Same login/password
1.if member of several networks linked to ECAS
2.for CIRCA BC
•
Before to access the RAB system the user will have to
register via this system.
•
First validation of the access will be done by EC.
•
A local administrator can validate accesses for his/her
organisation colleagues.
•
Other stakeholders' access will be managed by the ECSANCO-SoHO team
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ECAS: CREATE A PERSONAL ACCOUNT (1)

ECAS: European Commission Authentication Service

This system provides the user with a login and password to
connect to multiple European Commission applications.

Remark: Please do not create generic accounts.

URL: https://webgate.ec.europa.eu/cas/login
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ECAS: CREATE A PERSONAL ACCOUNT (2)
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ECAS: CREATE A PERSONAL ACCOUNT (3)
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ECAS: FIRST LOGIN (1)

URL: https://webgate.ec.europa.eu/ratc
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ECAS: FIRST LOGIN (2)
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SAAS: REQUEST AN ACCESS TO RAB (1)

SAAS: SANCO Authentication and Authorisation System

This system provides the user with a profile and access rights for a
specific European Commission application, in this case the RAB.

Remark: SAAS provides also administration interfaces to the Local
Admin.

URL: https://webgate.ec.europa.eu/saas
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SAAS: REQUEST AN ACCESS TO RAB (2)
Select the application:
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SAAS: REQUEST AN ACCESS TO RAB (3)
Select your organisation:
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SAAS: REQUEST AN ACCESS TO RAB (4)
Select your profile:
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SAAS: REQUEST AN ACCESS TO RAB (5)
Click on this button to validate your choice.
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RAPID ALERT ON SOHO - PLATFORM
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SYSTEM OVERVIEW: DASHBOARD
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ALERTS WORKFLOW
CA initiator
CA Reporter
CA Notified
All the notified CA (inlcuded affected CA)
Legend
Objects
Actions
New alert
Once the alert is created the
CA can directly submit the
alert to the notified CA
1
Alert status
Final report status
Conditional operator
The alert can be saved as draft
before to be sent to the other CA
Edit Alert
Comments
An email with a weblink to
access the alert is sent to the
CA notified.
[Submit]
[Update]
2
The notified CA will have to
confirm if they are affected or
not.
An email will be sent to the CA
initiator with the answer.
Notified
Draft
[Cancel]
[Is ready to Close]
Confirm or Deny
you are affected
At any time the CA
will be able to say if he is
affected or not.
[Confirm or Deny]
4
Edit report
Forward will not be
available if alert type is
‘Inquiry’
Update alert
[Delete]
New final
report
[Submit]
Draft
Deleted
Submitted for comments
[All required fields filled in]
[Add comment]
Add a comment to
the alert
5
[Forward]
Forward the alert
to another CA
[Confirm/Deny Affliction]
Confirm or Deny
you are affected
Closed
3
Choose a CA for
final report
Submitted for final report
Only ‘Affected’ CAs will have
the possiblity to comment the
final report
Once the alert has been sent
for the final report, no updates
or forwards are allowed
anymore
5
Comment Final
report
[No comment]
[Can be closed]
Close alert
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MAIN SYSTEM FEATURES - ALERT
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MAIN SYSTEM FEATURES – FINAL REPORT
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SYSTEM OVERVIEW: NEW ALERT SCREEN (1)
Type of alert:
•
Quality and safety
•
Information notice
•
Epidemiological alert
•
Inquiry (only between two
Member States)
•
Other
Component concerned:
• Plasma
• Platelets
• Whole Blood
• Red Blood Cells
• More than one blood
component
• All blood components
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SYSTEM OVERVIEW: NEW ALERT SCREEN (2)
Treatment/Specification:
 Apheresis
 Autologous
 Buffy coat removed
 Cryoprecipitate
 Cryoprecipitate-depleted
 Fresh-frozen plasma
 Frozen/cryopreserved
 Granulocytes
 In additive solution
 Irradiated
 Leucocyte-depleted
 No additional specifications
 Pathogen inactivated
 Pooled
 Recovered
 Single unit
 Thawed
 Washed
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SYSTEM OVERVIEW: ALERT SCREEN (3)
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SYSTEM OVERVIEW: NEW ALERT SCREEN (4)
Prescribe activities:
•
•
•
•
•
•
•
Collection
Testing
Processing
Storage
Distribution
Transport
Other
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SYSTEM OVERVIEW: NEW ALERT SCREEN (5)
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SYSTEM OVERVIEW: ALERT SUMMARY
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SYSTEM OVERVIEW: FINAL REPORT DETAILS
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NOTIFICATIONS/REMINDERS
 The notification will be done via email and will contain only a link to redirect
the user to the alert detail/personal data
 When the user will be notified by email?
When the alert is submitted to the CA and other stakeholders
 Each time a comment is added to the alert (by notified / affected CA)
 Each time the alert is forwarded to another CA (by notified / affected
CA)
 Each time the alert is updated by the CA initiator
 When a notified CA confirm or not he is affected by the alert
 When a CA is assigned to write the final report
 When the final report is submitted for comments (only to affected CA)
 When the alert or the final report is closed (all notified CA and other
stakeholders)
 When the user will receive a reminder?
 5 days after submission for confirmation to be affected, to remind the
CA to confirm or not (4 times 5 days – after is per default not
affected)
 10 days after the submission for comments of the final report, to
remind the CA to provide comments
 Once per month to remind a Competent Authority to check RATC
for news.

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RAB DATA PROTECTION
1. Data Protection Notification (linked to
RATC)
2. Privacy Statements for Users
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RAB SUPPORT
1. Functional mailbox SANCO-RAB@ec.europa.ec
2. Help/Frontdesk dedicated to RAB – technical and operational
questions.
3. Quick User Manual by January 2014
4. SoHO team to provide support on business questions.
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RAB STANDARD OPERATING PROCEDURES (1)
1. RAB SOP as reference document
2. Available to all RAB users
3. In line with the RAB Workflow and User Manual
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RAB STANDARD OPERATING PROCEDURES (1)

Type of Alerts: The alerts can be related to:
 outbreaks of communicable diseases;
 defects of Medical devices, tests;
 defects on products used for processing blood or blood products;
 import and export issues of blood products;
 Other types.

Criteria to report an alert using the RASB are:
 Quality/Safety perspective for blood of a serious or potentially
serious nature;
 A known risk to patients, or potential patients, in Member States;
 With wider public health implications.
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RAB CASE STUDIES (HANDS-ON)
1. Scenarios (alerts already submitted)
2. One country each user
3. Play as in a real alert
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RAB: NEXT STEPS
1. RAB launched on the first week of February 2014
2. First training course 15th January 2014 in Brussels;
15 Member States
3. Second Training course April 2014.
4. CIRCABC as back-up system
5. Alive project – the platform hosts Blood and T&C
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ACKNOWLEDGEMENTS
Thanks to the DG SANCO, Unit D4 Substances of human
origin (SoHO) and Tobacco control
Special Thanks to Paolo CATALANI
And to the Experts of the RAB WG
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Thank you
Agence nationale de sécurité du médicament et des produits de santé
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Avertissement
• Lien d’intérêt : personnel salarié de l’ANSM (opérateur de l’Etat).
• La présente intervention s’inscrit dans un strict respect d’indépendance et
d’impartialité de l’ANSM vis-à-vis des autres intervenants.
• Toute utilisation du matériel présenté, doit être soumise à l'approbation préalable
de l’ANSM.
Warning
• Link of interest: employee of ANSM (State operator).
• This speech is made under strict compliance with the independence and
impartiality of ANSM as regards other speakers.
• Any further use of this material must be submitted to ANSM prior approval.
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