Saatja: <
[email protected]>
Saadetud: 04.10.2023 18:01
Adressaat: <
[email protected]>
Koopia: <
[email protected]>
Teema: Follow-up meeting on the development of the EU SoHO platform and
call for volunteers
Dear National Authorities for blood & blood components and for
tissues & cells,
We were pleased to welcome you to the virtual meeting organised to update
you on the status of the development of the EU SoHO platform back on
Thursday 31 August 2023.
As agreed, please find attached a copy of the presentation.
We have mentioned several times that the platform will be developed FOR
YOU and WITH YOU. Therefore this is the moment to express your interest
to collaborate in the different phases of the development and piloting of
the process and in the definition of the common data model. We expect
that development will really start 1st half of 2024 with possible pilots
as from end of the year.
Should you wish to be engaged and contribute in this development, please
send us an email and mention which modality(ies) is (are) of your
interest ( you can use the corresponding number). A screenshot of the
wheel is reported below for your convenience.
1) Registry of entities and their authorisation
2) Compendium of authorised SoHO preparations
3) SoHO Coordination Board membership and compendium of opinions given
4) Vigilance and reporting. Rapid alerts
5) Activity data supply flows monitoring. Supply alerts for critical SoHO
6) Technical guidelines for implementation of standards
7) Member State National and other SoHO competent authorities
The deadline is set to Tuesday 31 October 2023, but we will be happy to
welcome you anytime.
Should you have any question, do not hesitate to contact us at
Best regards,
The SoHO team.
European Commission DG SANTE (Health and Food Safety)
Unit D2 Medical Products: quality, safety, innovationOffice address: Rue
Breydel 2, 06/004, B-1049 Brussels/Belgium
Status of the development of the EU
SoHO platform
Joint Meeting of the Competent Authorities for Blood & Blood
Components and Tissues &Cells
31 August 2023
Health
AGENDA
1. Welcome, introductory remarks and agenda
2. Functionalities of the EU SoHO platform
3. Supporting contracts
4. Existing national platforms
5. Next steps
6. Q&A
7. Final remarks
Scope of today’s exchange
• Common picture of SoHO platform functionalities
• Based on the COM proposal for a new SoHO regulation – might still
evolve (but not here)
• Current state of play - work in progress
• Authorities are key users, need your inputs and steer
• Manage expectations
• Get basic working solutions
• Recycle national and EU systems
Proposal for a Regulation published in July 2022
https://health.ec.europa.eu/blood-tissues-cells-and-organs/overview/proposal-regulation-substances-human-origin_en
Digital Functionalities to support implementation of the
SoHO regulation
Registry of
entities and
their
authorisations Compendium
Member State
of authorised
National and
SoHO
other SoHO
preparations
competent
authorities
The EU SoHO
SoHO Coordination
Board
Technical
guidelines for
Platform Membership
and
implementation compendium of
of standards opinions given
Activity data
and supply Vigilance
flows reporting
monitoring
Rapid alerts
Supply alerts
for critical Soho
Important to tailor to variety of organisational
models
SoHO Actors
• Flexible and scalable
• > 5,000 (often small) authorised establishments (today) solutions needed to
• Adding entities across many healthcare providers address variety
• Different SoHO sectors, different organisational models • Public actors and
authorities, with
• Many public services, academic hospitals, non-profit limited resources
sector (e.g., Red Cross)
• Professional and scientific societies can be facilitators • Potential to
add/support admin
SoHO authorities efficiency
• Large vs small countries: different possibilities to
have/use own data-solutions
• Central vs regional authorities
• Consolidated vs sector-specific authorities
• Standalone vs integrated with pharma/devices
Overview of process
• Feasibility Study
• UX (User eXperience) support
• (pre-) Analysis and Design (external contractor)
• Iterative prototyping and further analysis
• Iterative development until the version 1.0 “MVP+”
Key concerns to consider Recycle common work
(EuroCET, EDQM)
1. Data Harmonisation and Reporting: Need to harmonize
data, classifications, vocabulary, definitions.
Verification by CA’s before 2. Data governance: ownership, access, role ofNo personal data at EU-
NCAs,
publication publication… level needed, but for
some alerts (as-in
3. GDPR, Privacy: How will the EU SoHO Platform ensureand
RAB/TC), datapossibly
privacy and security? Ensure access to personal data
on responsible persons
in entities
4. IT Systems: How to connect existing IT systems to the EU
direct entry by
SoHO Platform (connectivity) + possibilities for direct entry
Interviews with future
entities/establishments into Build on existing
SoHO-X, and/or upload of data 5. Common users and rules: e.g., when to send a rapid alert?
practices
users- early
collected insights
in existing (e.g., -
6. Cultural acceptance and transition: How can we ensure that
concerns
national)to address
databases
SoHO entities can adapt to the new requirements in a fast and
correct way? Map national IT-systems + clarify EU-
7. Communication – how to react specs, soSource
on IT EU andSystems
nationalchange
IT-plans can
(architecture, database etc) in the future ? align
EU4Health supported
actions for entities 8. Automation – leverage potential of IT systems to lighten
(professional societies), admin workload for entities and authorities
for CA’s
Let platform take over some work (draft
vérifications, draft consolidation data
reports, …)
AGENDA
1. Welcome, introductory remarks and agenda
2. Functionalities of the EU SoHO platform
3. Supporting contracts
4. Existing national platforms
5. Next steps
6. Q&A
7. Final remarks
1. Registration of SoHO entities and their authorisations
Registry of
entities and
their
authorisations Compendium
Member State
of authorised
National and
SoHO
other SoHO
preparations
competent
authorities
The EU SoHo
SoHO Coordination
Board
Technical
guidelines for
Platform Membership
and
implementation compendium of
of standards opinions given
Activity data
and supply Vigilance
flows reporting
monitoring
Rapid alerts
Supply alerts
for critical Soho
a. Legal 1/2: all SoHO activities that directly
impact safety or quality need to be registered
Donor History Review
&
Eligibility Assessment
Donor Distribution Clinical
Donor Export Outcome
Testing
Recruitment Monitoring
Import
Requires registration as SoHO entity
a. Legal 2/2: some SoHO entities require an
authorisation
1. SoHO entities must be
SoHO Entities
registered
2. Some entities
also need an
authorisation
Processing and
storing SoHO 2a. Must be registered, authorised,
and inspected as a SoHO
establishment
Importing 2b. Must be registered
SoHO
and authorised as an Importing
SoHO Entity
b. What we have so far…
• Workshops in NCA meetings: 07 February (T&C) and 25 April (Blood)
• Draft process
• Draft mock-ups (look&feel)
• External contractors’ work: use cases specifications and business process
c. (Standard) Flow: SoHO entities register on SOHO-X
A B C
Entity registration is published
Entity Registers CA accesses and Only if entity ... Same as in option 1
on SOHO-X 1. processes and stores
verifies if entity:
2. imports SoHO
3. …
1. (is critical)
2. needs authorisation D E
1. as SoHO
establishment
2. to import
3. …
CA updates the entity record
1. SoHO establishment authorisation
CA carries out the steps to
2. Importing SoHO entity authorisation
authorise as relevant
(outside of platform) 3. …
DRAFT
c. Digital flow as from first registration as entity…
In SoHO digital platform
(COM SoHO proposal)
Acknowledgement of registration
Entity If needed, receives request for further information
Receives
Registers on Informed to be Critical confirmation
SoHOx
Informed of need for
authorisation(s) with
instructions for application
Auto (P&S, I, …)
Application(s)
C.A. Accesses entity's registration on platform
Auto Authorization: Keep
• .
registration
1. Inspects + grants Establishment
Reviews completeness authorisation
information up
to date
of information + verifies +
2. Desk-based review + grants
publishes entity in SoHO- authorisation as importing SoHO
X + ... entity
1. If entity is critical – informs entity and 3. …
flags on register (C)
Auto
2. If entity needs an auhthoisatiion as it…
1. processes and stores –
informs entity of steps to take to
be authorised as establishment
(P&S)
2. imports SoHO – informs entity Updates and
of steps to take to be publishes in
authorised for import (I)
3. … SoHO-X
DRAFT
d. Look & feel
Registration form: coordinates,
SoHO-type, activities, scale,
contact/responsible person, …
16
DRAFT
d. Look & feel
17
EU Coding Platform (europa.eu), following COM Directive 2015/566
e. Open questions and user engagement
• (Main) open questions
• Alternative pathway to leverage (existing) national registries – interconnect to upload ?
• Module for local/national process to apply and authorize (importing) establishments ?
• Integration in EU Coding platform (possible reuse) or development of new compendia with
same look and feel ?
• …
• User Engagement
• Map out existing national initiatives/registries (agenda point 4.)
• User group: call for interested authorities
• Transition stage: help to upload of 4000+ authorized tissue establishment (SEC)
• Training for eventual users (e.g., SIGHT-SoHO, …)
• …
2. Authorizing SoHO preparations
Registry of
entities and
their
authorisations Compendium
Member State
National and
of authorised
other SoHO SoHO
competent preparations
authorities
The EU SoHo
SoHO Coordination
Board
Technical
guidelines for
Platform Membership
and
implementation compendium of
of standards opinions given
Activity data
and supply Vigilance
flows reporting
monitoring
Rapid alerts
Supply alerts
for critical Soho
a. Legal 1/2: Processing SoHO leads to SoHO
preparations
What is a ‘SoHO Preparation’?
A particular SoHO that has been subjected to one or Must be
more SoHO activities, including processing, with pre- authorised
defined specification and specific clinical indication
SoHO SoHO
Preparation
Example: Plasma
Blood
Red blood cells
Platelets
a. Legal 2/2: SoHO preparation(s) require an
authorisation Article 21
Must be Vigilance &
SoHO Entities registered activity reports
Processing > Must be authorised
SoHO
preparations
b. What we have so far…
• Joint Action GAPP: Facilitating the Authorisation of Preparation Process for
blood, tissues and cells (gapp-ja.eu))
• Developed authorization process
• Tested risk assessment tool (EuroGTP-2)
• Made a first map of existing preparations
• IT blueprint
• Meeting with NCAs involved in GAPP II (Joint Action) 10 November 2022
• External contractors’ work: use cases specifications, business process
b. Development SoHO Preparation
Authorisation process (GAPP-JA) • Use EuroGTP2
tool or similar
• Taking into
account any
relevant EDQM
1 Systematic Risk Assessment to determine the requirements for authorisationmonograph
2 Submission of an application dossier, including laboratory validation and,
where relevant, a clinical outcome monitoring plan proportionate to risk
3 Assessment of the application by the competent authority
Grant of a Refuse
Grant
OR conditional OR authorisation
authorisation
authorisation to
allow evidence
gathering
+ blueprint for
4 Assessment by the competent authority of evidence gathered the
auhorisation
Grant Refuse submission/
OR authorisation
authorisation assessment
(WP8 GAPP)
Based on preparatory work done by GAPP Joint Action
(incl. stakeholders from 17 countries: 15 CAs & professional associations)
b. Developments clinical Outcome Monitoring
Plans for Conditional authorisation (GAPP-JA)
comparison
+ to standard
therapy
clinical investigation study with
+ appropriate number of patients
No clinical
and pre-defined clinical endpoints
outcome
monitoring
required Clinical follow-up of a defined number of patients is required
Negligible Low Moderate High
Risk Risk Risk Risk
Based on preparatory work done by GAPP Joint Action
(incl. stakeholders from 17 countries: 15 CAs & professional associations)
c. (Standard) Flow: SoHO entities can apply for a SoHO
preparation authorisation
A B C
Entity registration is published
Entity Registers CA accesses and Only if entity ... Same as in option 1
on SOHO-X verifies if entity: 1. processes and stores
2. imports SoHO
3. processes
1. (is critical)
2. needs authorisation D E
1. as SoHO
establishment
2. to import
3. to process
CA updates the entity record
1. SoHO establishment authorisation
CA carries out the steps to
authorise as relevant 2. Importing SoHO entity authorisation
(outside of platform) 3. Authorized SoHO preparations per
entity/establishment
DRAFT
c. Digital flow as from first registration as entity…
In SoHO digital platform
(COM SoHO proposal)
Acknowledgement of registration
Entity If needed, receives request for further information
Receives
Registers on Informed to be Critical confirmation
SoHOx
Informed of need for
authorisation(s) with
instructions for application
(P&S, I, P)
Application(s)
C.A. Accesses entity's registration on platform
Authorization: Keep
• .
registration
1. Inspects + grants Establishment
Reviews completeness authorisation
information up
to date
of information + verifies +
2. Desk-based review + grants
publishes entity in SoHO- authorisation as importing SoHO
X + ... entity
1. If entity is critical – informs entity and 3. Review application + grant
flags on register (C) (conditional) authorization for
SoHO preparation
2. If entity needs an auhthoisatiion as it…
1. processes and stores –
informs entity of steps to take to
be authorised as establishment
(P&S)
2. imports SoHO – informs entity Updates and
of steps to take to be publishes in
authorised for import (I)
3. Processes (P) SoHO-X
DRAFT
d. Look & feel – compendium of SoHO
preparations authorised in the EU
27
EU Coding Platform (europa.eu), following COM Directive 2015/566
DRAFT
d. Look & feel – authorised (processing)
activities per entity
Complemented with info
on specific authorized
preparations
28
EU Coding Platform (europa.eu), following COM Directive 2015/566
e. Open questions and user engagement
• (Main) open questions
• Module for local/national process to apply and authorize SoHO preparations ?
• Integrate tools to make risk-assessments (EuroGTP-2) ?
• Integration in EU Coding platform (possible reuse) or development of new
compendia ?
• …
• User Engagement
• Map out existing national initiatives/registries (see agenda 4.)
• Map out authorized preparatons (GAPP/GAPP-pro)
• Call for interested authorities to co-develop (GAPP-pro?)
• Training for eventual users (e.g., SIGHT-SoHO, …)
3. Platform for (views of) SoHO Coordination Board
Registry of
entities and
their
authorisations Compendium
Member State
of authrisated
National and
SoHO
other SoHO
preparations
competent
authorities
The EU
SoHO SoHo
Coordination
Technical
guidelines for
Platform Board
Membership and
implementation compendium of
of standards opinions given
Activity data
and supply
flows Vigilance
monitoring reporting
Supply alerts Rapid alerts
for critical Soho
a. Legal: SCB supports MS to implement the Regulation by
providing best practice guidelines and opinions on
regulatory status
Online library for
Documentation of best documents from and for Opinions on
practices for competent authorities regulatory status
supervisory
of preparations
functions: SCB
• Inspection
• Vigilance Chair & Secretariat:
Record of:
• Authorisation Commission
• national
Members: decisions on
2 per Member State (NA/MoH) regulatory
status
Observers: • Compendium of
Support for joint Union bodies/institutions/agencies
opinions given
oversight & other invitees
on regulatory
measures status
- inspections
- authorisations
Online compendium for (a)
EU level opinions and (b)
Collaborative space Interactions National decisions
Advisory Expert
CA’s bodies in bodies –
other ECDC/
legislative EDQM
frameworks
b. What we have so far…
• Guidance documents and user manuals on …
• vigilance (VES)
• inspections (IES)
• Authorisations (GAPP)
• Coding/traceability using the SEC (CES)
• External contractors’ work: use cases specifications, business process
d. How it could look
• Online library guidance documents
• Online compendium legal advice
• Collaborative space CA’s
• Online SCB membership
e. Open questions and user engagement
• (Main) open questions
• Recycle or purchase commercially developed tools ?
• Can SIGHT-SoHO start compilation of training materials for library ?
• Integration in EU Coding platform (possible reuse) or development of new compendia with
same look and feel ?
• …
• User Engagement
• Send in useful examples/tools
• User group: call for interested authorities
• Role participants SIGHT-SoHO community,
• Continue with CA members Expert Subgroups (IES, VES, GAPP-PRO)
• …
4. Vigilance reporting and alerts
Registry of
entities and
their
authorisations Compendium
Member State
of authorised
National and
SoHO
other SoHO
preparations
competent
authorities
The EU SoHo
SoHO Coordination
Board
Technical
guidelines for
Platform Membership
and
implementation compendium of
of standards opinions given
Activity data
and supply
Vigilance
flows reporting
monitoring
Rapid alerts
Supply alerts
for critical Soho
a. Legal: Vigilance overview
SoHO Send SAO notification & SAO
Entities investigation report to their CA
• Aggregate the
summaries from the
SoHO National
Authorities
• Verify info of SAO
• publish annual
notifications & investigation
SoHO vigilance
Competent reports, assess the results of
report
Authorities the investigation, informs the
entity
• Launch SoHO rapid alerts
• Send annual summary of
SAO notifications & • Submits annual
investigation reports received summary to the EU
to their SoHO National SoHO Platform
Authority • Publishes aggregated
Communication with
summary for their MS
CAs from other
frameworks
b. What we have so far…
• Well-established vigilance systems under Directives 2002/98/EC and 2004/23/EC,
including …
• reporting templates/forms (establishment to authority)
• rapid alert systems (RAB/TC)
• annual data collection and consolidation SARE (per MS, EU-wide)
• Guidance Vigilance Expert Subgroup (VES) for annual data reporting reporting
(common approach)
• External contractors’ work: use cases specifications, business process and mock-
ups
DRAFT
c. Draft Digital flow In SoHO digital platform
(COM SoHO proposal)
Donor / Platform nice to have
Recipient
Communicates
Self report SAO
SoHO SoHO Submits SAO + Competent Submits SAO Annual report National
Entity A Entity B Investigation report Authority B + Investigation report Authority B
Communicates
Submits (updates/closes)
ECDC Submits Country B
RAB / RATC
SAO Annual report
+ Investigation
Acknowledges
(updates/comments)
Competent
Informs European Commission
Authority A
Publishes
Platform must have Annual
Report
DRAFT
d. How it could look – rapid alerts
ANNEX III
National
NOTIFICATION OF SERIOUS ADVERSE REACTIONS Tissue Competent
Establishment Authorities
PART A
Rapid notification for suspected serious adverse reactions
Tissue establishment
Report identification
Reporting date (yearfmonthfday)
Other NCA's T&C
Individual affected (recipient or donor) Other sectors
Date and place of procurement or human application (yearfmonthfday)
Unique Donation identification number
Date of suspected serious adverse reaction (yearfmonthfday)
Type of tissues and cells involved in the suspected serious adverse reaction
Type of suspected serious adverse reaction(s)
39
RAB/RATC platform (europa.eu)
DRAFT
d. How it could look – annual reports
National
Competent
Authorities
European
Commission
(EDQM)
40
Summary of annual reporting of serious adverse reactions and (europa.eu)
e. Open questions and user engagement
• (Main) open questions
• Secure communication channel entity/authority to integrate model for national
process/forms to submit and follow-up on SAO ?
• Allow SoHO-digital platform to auto-prepare (draft) annual consolidated reports (per MS,
for EU) ?
• Re-use existing RATC platform - ask VES proposal for RATC platform improvement and
extension to non BTC ?
• …
• User Engagement
• User group: continue with NCA’s members of VES
• …
5. Supply (monitoring and) alerts
Registry of
entities and
their
authorisations Compendium
Member State
of authorised
National and
SoHO
other SoHO
preparations
competent
authorities
The EU SoHo
SoHO Coordination
Board
Technical
guidelines for
Platform Membership
and
implementation compendium of
of standards opinions given
Activity data
and supply Vigilance
flows reporting
monitoring
Rapid alerts
Supply alerts
Activity data overview
• Supports MS policies
for supply sufficiency
• Provides
denominators for SAO
reports
• Gives visibility to
citizens
SoHO
Entities
May
delegate Submit annual summary of data collected to the EU SOHO Platform
Existing
professional
registries Publish annual
Competent SoHO activity
(that collect data on
the relevant Authorities report
activities) - Verify that their entities have
submitted complete & accurate
Conditional on summaries
CA verification of
data quality - Publish aggregated annual
report for their SoHO entities
a. Legal: Which data?
SoHO activities for which data shall
* be collected
Donor History Review
&
* Donor
Eligibility Assessment
Recruitment
Donor
Testing
* Export
Distribution
*
Clinical
Outcome
Monitoring
* *
Import
*
b. What we have so far…
• Exercises to harmonise activity data collection exercises in the field of tissues and
cells in Europe (EuroCET, EDQM)
• Preparedness planning blood sector (B-SCEP, EDQM)
• Guidance Vigilance Expert Subgroup (VES) for annual data reporting reporting
(common approach) and
• Extenal contractors’ work: use cases specifications, business process and mock-
ups
• External contractors’ workshop with EDQM and relevant stakeholders
DRAFT
c. (standard) digital flow
In SoHO digital platform
(COM SoHO proposal)
Article 33, 44
Submits a report of
annual activities in Can access and query
Entity SoHO platform public report, dashboards
Competent Verify the submissions Compiles annual report
Can access and query
(completeness and per CA and …
Authorities own data, dashboards
accuracy)
… Publish report
Aggregate the annual summaries of the
EC SoHO entities, prepare and …
Publish an Annual SoHO Activity Report.
DRAFT
c. Digital flow In SoHO digital platform
(COM SoHO proposal)
Donor / Platform nice to have
Recipient
Communicates
Self report SAO
SoHO SoHO Submits SAO + Competent Submits SAO Annual report National
Entity A Entity B Investigation report Authority B + Investigation report Authority B
Communicates
Submits (updates/closes)
ECDC Submits Country B
RAB / RATC
SAO Annual report
+ Investigation
Acknowledges
(updates/comments)
Competent Relevant
Informs European Commission
Authority A National Authority
Submits
Supply Alert
Publishes
Platform must have Annual
Report
Critical Competent National
Launches Supply Alert Informs
SoHO Entity Authority Authority
e. How it might look - EU
Cornea
activity
data in
Cornea collection 2029!
Fictional
data!!!
Cornea application
Cornea distribution
inter-MS
Cornea export
e. How it might look – zooming in to one MS
Cornea
activity data
in 2029 -
one
Member
Cornea collection
State!
Fictional
data!!!
Cornea application
Cornea distribution
inter-MS
Cornea import
• Supports MS
policies for supply Cornea export
sufficiency
• Provides
denominators for
SAO reports
• Gives visibility to
citizens
e. How it could look like – supply alerts
ANNEX III
National
NOTIFICATION OF SERIOUS ADVERSE REACTIONS Tissue Competent
Establishment Authorities
PART A
Rapid notification for suspected serious adverse reactions
Tissue establishment
Report identification
Reporting date (yearfmonthfday)
Other NCA's T&C
Individual affected (recipient or donor) Other sectors
Date and place of procurement or human application (yearfmonthfday)
Unique Donation identification number
Date of suspected serious adverse reaction (yearfmonthfday)
Type of tissues and cells involved in the suspected serious adverse reaction
Type of suspected serious adverse reaction(s)
50
RAB/RATC platform (europa.eu)
e. Open questions and user engagement
• (Main) open questions
• Integrate a local/national channel entity/authority to report supply situation/issues ?
• Alternative pathway to use/recycle data reports to existing registries – upload,
interoperability ?
• Reuse (RAB/TC) tools for reporting vigilance alerts adapted for the management of supply
alerts ?
• Allow SoHO-X to prepare (draft) annual consolidated reports (per MS, for EU) ?
• Coordinate with/recycle non-SoHO supply monitoring efforts post-COVID (EMA, HERA,
…)?
• User Engagement
• User group: continue with NCA’s members of VES
• Engage EuroCET, engage members EDQM work BSCEP
• …
6. Technical guidelines
Registry of
entities and
their
authorisations Compendium
Member State
of authorised
National and
SoHO
other SoHO
preparations
competent
authorities
The EU SoHo
SoHO Coordination
Board
Technical
guidelines for
Platform Membership
and
implementatio compendium of
n of standards opinions given
Activity data
and supply Vigilance
flows reporting
monitoring
Rapid alerts
Supply alerts
for critical Soho
a. Legal: cascade of technical guidelines
SoHO entities shall follow the highest available levels of standards (Art. 56 & 59):
“where the Commission
Level 1 Commission Implementing Legislation deems necessary”
If none: Published & updated“Inspectors
a. Technical Guidance on the EU SoHO by ECDC/EDQM shall accept”
Level 2 Platform
OR:
Deemed by CAs to achieve “Entities shall demonstrate
b. “Equivalent” equivalent standards equivalence to inspectors”
Guidance
If none:
Methods based on international standards or scientific evidence
Level 3
“Entities shall demonstrate
equivalence to inspectors”
Single-place acess to all guidelines:
• Expert bodies, and where relevant corresponding…
• … COM implementing legislsation
• … National equivalent (and more stringent)
guidelines
b. What we have so far…
• (Commission technical standards in EU and COM Directives)
• Expert bodies’ guidance:
• Guidelines EDQM (pdf)
• Recommendations ECDC (pdf)
• External contractors’ work: use cases specifications, business process
• External contractors’ workshop with ECDC EDQM
c. Draft Digital flow
• To be discussed with EDQM and ECDC
d. How it could look like – from pdf to …
e. Open questions and user engagement
• (Main) open questions
• Coordination and aligned planning EDQM and ECDC ?
• One map referring to possible alternative (a) over-ruling COM guidelines and/or (b)
national equivalent or more stringent requirements ?
• Align digital formatting and planning with EDQM and ECDC ?
• …
• User Engagement
• User group: call for interested authorities, EDQM + ECDC
• …
7. Compendium of authorities
Registry of
entities and
Member their
State authorisations Compendium
National and of authorised
SoHO
other SoHO preparations
competent
authorities
The EU SoHo
SoHO Coordination
Board
Technical
guidelines for
Platform Membership
and
implementation compendium of
of standards opinions given
Activity data
and supply Vigilance
flows reporting
monitoring
Rapid alerts
Supply alerts
for critical Soho
a. Legal: national set-ups Competent
Authorities
2 Main Roles:
Other
Non-SoHO SoHO Coordination
SoHO National Authorities Board
Authorities
of other Member States
a. Liaison & Cooperation
a. One SoHO
Ministry of Health National Authority
Designation
& support
b. Possible other SoHO
Delegated Bodies Competent Authorities
(according to national healthcare system, b. SoHO Supervisory Activities
e.g., per region, per substance, …)
SoHO
Establishments and entities
b. What we have so far…
• Compendium CA’s tissues and cells (Single European Coding platform)
• External contractors’ work: use cases specifications, business process and mock-
ups
d. Look&Feel
Per authority (matrix):
• Geography
• SoHO type
• Oversight activity
EU Coding Platform (europa.eu), following COM Directive 2015/566
e. Open questions and user engagement
• (Main) open questions
• Matrix: per mandate (authorisation, inspection, …) per substance, per geography ?
• Integrate mandates of delegated bodies ?
• Reuse of currently existing CA compendia in RATC platform ?
• …
• User Engagement
• User groups: IES, VES, OVERSIGHT, GAPP-JA
• …
AGENDA
1. Welcome, introductory remarks and agenda
2. Functionalities of the EU SoHO platform
3. Supporting contracts
4. Existing national platforms
5. Next steps
6. Q&A
7. Final remarks
Overview of process
• Feasibility Study
• UX (User eXperience) support
• (pre-) Analysis and Design (external contractor)
• Iterative prototyping and further analysis
• Iterative development until the version 1.0 “MVP+”
Roadmap / Key milestones
14/12 31/08
2022 2023 2024 2025
05/04 PIR 14/07 Regulation proposal
Feasibility study
(DIGIT)
UX coaching
(DIGIT UX Lab)
Analysis & Design
(“extra-muros” team)
- Preliminary
- requirements Cloud prototype
- specifications (“extra-muros” team)
- prototype
- User Journey Map
- Cloud architecture
- Releases 0.1, 0.2, 0.3
- Project Charter (in TEST only)
- Requirements
- Specifications SOHO-X development
- Security BIA (internal team)
- Data Protection
- Analysis of IS reuse
- Architecture & reuse
- Automated testing
- Releases 0.1 to 1.0 (PROD)
- Security Plan
3.1. Feasibility study
Scope:
First draft IT processes and related costs for:
- Architecture
- Data
- Users & Security
Methodology:
- Interviews with SANTE staff, Coding Expert Subgroup, Vigilance
Experts Subgroup (belonging to NCA), and stakeholders
- Collection and study of existing documents
Outcome:
- Preliminary business process analysis
- Preliminary functional requirements and use case analysis
- Preliminary IT architecture
3.2. DIGIT UX Lab support
Scope:
Design a new product putting the user experience at the centre
Methodology:
- Workshops with SANTE team, ECDC/EDQM, NCAs
- Interviews with entities, establishments, competent authorities
and stakeholders
- Collection and study of existing documents
Outcome:
- Ecosystem map / Stakeholders map
- Personas / User journey maps
- Draft low fidelity prototypes
3.3. Pre-analysis
Scope:
- Consolidate, update, elaborate on the user requirements, existing
or new, and turn them into functional specifications, security and
data protection requirements.
- Analyse the opportunity to reuse existing or being developed
information systems.
Methodology:
- Workshops with SANTE team, ECDC/EDQM, NCAs
- Interviews with entities, establishments, competent authorities
and stakeholders
- Collection and study of existing documents
Outcome:
- Requirements and functional specifications
- Security business impact assessment
- Data protection requirements
- Study of reuse of existing IT systems
Platform components
Registry of
entities and
their
Member State Registration
authorisations
National and
other SoHO Publication
competent Collaborative Compendium
authorities space of authorised
SoHO
Registration
Publication preparations
Publication
The EU SoHo
SoHO Coordination
Board
Technical
guidelines for Platform Membership
and
Collaborative
implementatio compendium space
n of standards of opinions
Publication given Publication
Reporting &
Activity data Vigilance monitoring
and supply reporting Notifications &
flows
monitoring alerts
Reporting & Rapid alerts
Collaborative
Supply alerts monitoring
space
Notifications &
alerts Publication
3.4. Prototyping
Scope:
- Study the suitability and alternatives for cloud native development
- Including security constraints ("Sensitive Non-Classifed" compliant
environment)
- Recommendations on how to move from “traditional” 3-tier web
applications to cloud-native on the chosen cloud provider
- Architecture of the SOHO platform on the cloud
- Define and configure cloud-native or cloud-compatible
DevSecOps and container tooling and processes
- Build a cloud-native prototype
- Common Data Model for system-to-system data exchange
Methodology:
- Continuous analysis and iterative development
- Close collaboration with internal IT team
Outcome:
- Cloud architecture
- Cloud development recommendations
- Incrementally-built EU SoHO Platform prototype
3.5. Development and transition to production
Scope:
Methodology:
- Continuous analysis and iterative development
- Close collaboration with prototyping team
- Further IS reuse analysis and integration approaches
- Reuse of EC corporate “building blocks” (EU Login, eUI, etc.)
- Automated testing
Outcome:
- Security plan
- Technical Specifications and Architecture
- Incrementally-built EU SoHO Platform in production: MVP+
- MVP: Minimum Viable Product (legal requirements)
- +: Complemented by other essential features
- External interfaces specifications (interoperability)
- User manual and other documentation
AGENDA
1. Welcome, introductory remarks and agenda
2. Functionalities of the EU SoHO platform
3. Supporting contracts
4. Existing national platforms
5. Next steps
6. Q&A
7. Final remarks
Mapping of NA information systems
Study to be launched
Prerequisites: completed business process modelling and specifications
Identification of existing systems at the national level and their functional
coverage
Analysis of overlap with the EU SoHO platform processes and
specifications
Analysis of possible scenarios
A. Definition of interfaces (web services, Common Data Model)
B. Design of a reference implementation for a NA system
C. Full switch to the central application
D. Hybrid
Building an overview of (planned) national IT-
set-ups
…
A: have – requires
A interface to upload
Belgium
A
B
A B: will build - requires
Austria
B
A Reference specs
A
A C: will use central EU-tool
C
B
B
D: hybrid
B
B
C
C B B
B B
B D
AGENDA
1. Welcome, introductory remarks and agenda
2. Functionalities of the EU SoHO platform
3. Supporting contracts
4. Existing national platforms
5. Next steps
6. Q&A
7. Final remarks
Roadmap / Key milestones
14/12 31/08
2022 2023 2024 2025
05/04 PIR 14/07 Regulation proposal
Feasibility study
(DIGIT)
UX coaching
Mapping and
(DIGIT UX Lab)
interoperability study
Analysis & Design
(“extra-muros” team)
- Preliminary
- requirements Cloud prototype
- specifications (“extra-muros” team)
- prototype
- User Journey Map
- Cloud architecture
- Releases 0.1, 0.2, 0.3
- Project Charter (in TEST only)
- Requirements
- Specifications SOHO-X development
- Security BIA (internal team)
- Data Protection
- Analysis of IS reuse
- Architecture & reuse
- Automated testing
- Releases 0.1 to 1.0 (PROD)
- Security Plan
Release 0.1 Release 0.2 Release 0.3 Release 1.0
- Registration - Notifications - Collaborative - Interoperability
- Publication of and alerts space
technical guidelines - Reporting 1 - Indicators
- Publication 2 - Reporting 2
- Publication 3
What is next – key considerations
• User groups: call for interested authorities AND/OR leverage groups gathered already
• VES – guidelines/improvements RAB/TC, SARE reporting
• IES - guidelines
• GAPP-PRO – improved working methods
• SIGHT-SoHO – training materials/modules/web-platform
• Align with ECDC EDQM for publication of guidelines in web format
• Decide on levels of ambition per module (nice to have vs must have)
• Mapping of current national IT infrastructure at national level
• Assess potential/way to re-use existing EU platforms (RAB/TC, Coding/SEC)
• Target timeline: entry into force SoHO regulation (2026 - tbc)
• Three intermediate releases
• Release 1.0 before 2026 (“MVP+”)
AGENDA
1. Welcome, introductory remarks and agenda
2. Functionalities of the EU SoHO platform
3. Supporting contracts
4. Existing national platforms
5. Next steps
6. Q&A
7. Final remarks
AGENDA
1. Welcome, introductory remarks and agenda
2. Functionalities of the EU SoHO platform
3. Supporting contracts
4. Existing national platforms
5. Next steps
6. Q&A
7. Final remarks
Thank you