Introduction To SPOR Data Services

Introduction To SPOR Data Services

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Description: To provide Industry stakeholders with a base understanding of SPOR data services: why we need them, resulting changes and benefits, implementation approach. To signpost key reference material that will support Industry stakeholders in their planning to implement changes due to SPOR. To ensure Industry stakeholders are aware of how EMA plan to support them through engagement, communications and training activities.

 
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Contents:
Introduction to SPOR data
services
SPOR data services: Delivering quality data services on
Substances, Products, Organisations and Referentials to
power EU regulatory activities
4 August 2016
SPOR data services project team

An agency of the European Union
© EMA 2016

Contents



Objectives



The case for SPOR data services



Implementation of SPOR data services



SPOR engagement activity



Deep dive: Operating models

1

Introduction to SPOR data services
© EMA 2016

Objectives

1. To provide Industry stakeholders with a base understanding
of SPOR data services: why we need them, resulting
changes and benefits, implementation approach
2. To signpost key reference material that will support Industry
stakeholders in their planning to implement changes due to
SPOR
3. To ensure Industry stakeholders are aware of how EMA plan
to support them through engagement, communications and
training activities

2

Introduction to SPOR data services
© EMA 2016

The case for SPOR data services

3

Introduction to SPOR data services
© EMA 2016

The issue: lack of standardisation

Lack of standardisation…

• Different controlled vocabularies*
are used across different
organisations
• Names used for organisations
differ between, and sometimes
across different departments
within, NCAs and Industry
• Different names for substances
are used across different regions
in Europe and globally

• Data is often entered manually

Results in…
• Inconsistent data quality
and duplication
• Inefficiencies relating to correcting
data and investigating data
discrepancies
• Manual intervention required to
resolve data issues
• Slower decision-making
• Decision-making based on
inaccurate information

*Controlled vocabularies (aka Referentials) are lists of terms that refer to attributes of medicinal and
pharmaceutical products e.g. dosage form, route of administration, unit of measurement

4

Introduction to SPOR data services

© EMA 2016

Why do we need standardisation?
Standardised data will…
Pharmacovigilance

…improve signal detection and speed of response for authorised products, thus
improving protection of public health in EU

ePrescription

…support cross-border electronic prescriptions of medicines in EU enabling
patients to obtain the right products when outside their home country based on
standardised data

Falsified medicines

…support the mechanism for controlling authenticity of medicines

Shortages

…allow substances and products to be identified across countries enabling faster
response to address shortages

Batch recalls

…allow substances and products to be identified across countries enabling faster
identification and withdrawal

Inspections

…improve the link between the Supply Chain and the regulatory dossier since
inspectors will have better records available to support their findings on Manufacturing sites

Regulatory
activities

…facilitate process efficiencies in regulatory activities e.g. submission of regulatory
application forms and Variations

5

Introduction to SPOR data services

© EMA 2016

ISO IDMP will introduce standardisation
There is a legal obligation for Industry to make use of the terminologies defined in ISO IDMP
standards: Regulation (EU) No 520/12012 (art. 25 & 26)
“The use of internationally agreed terminology, format and standards should facilitate the interoperability of systems
used for the performance of pharmacovigilance activities and avoids the duplication of encoding activities concerning
the same information. It should also allow for an easier information exchange between regulatory authorities on an
international level”
Commission Implementing Regulation (EU) No 520/2012

The ISO IDMP standards establish definitions
and concepts and describe data elements and
their structural relationships. This enables the
the unique identification of:


Medicinal product information
(MPID/PCID) - ISO 11615



Pharmaceutical product information
(PhPID) - ISO 11616



Substances (Substance ID/Specified
Substance ID) - ISO 11238



Pharmaceutical dose forms, units of
presentation, routes of administration
and packaging - ISO 11239



Units of measurement (UCUM) - ISO
11240

ISO IDMP standards apply to both authorised
and investigational medicinal products for
Human use
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Introduction to SPOR data services

© EMA 2016

The solution: master data management
The identification, compilation and central management of pharmaceutical master
data will support compliance with ISO standards and respond to the need for
standardisation

The 5 new ISO IDMP standards are all about master data
Master data is any non-transactional information that is considered to play a key
role in the core operation of a business and is re-used for multiple purposes

Types of data:
Unstructured - data found in e-mail, white papers, magazine articles, corporate intranet portals,
product specifications, marketing collateral, and PDF files. (e.g. data in: product dossier, summary of
product characteristics)
Transactional – data related to sales, deliveries, invoices and other monetary and non-monetary
interactions. (e.g. application submission and approval dates)
Metadata - data about other data which may reside in XML documents, report definitions, column
descriptions in a database, log files, configuration files
Master – Any non-transactional data that is considered to play a key role in the core operation of a
business and is re-used for multiple purposes such as customer, product, site, supplier, vendor. (e.g.
Products, Substances, Organisations, Referentials)

7

Introduction to SPOR data services
© EMA 2016

Implementing ISO IDMP through SPOR

(1 of 2)

In the case of the regulated EU pharmaceutical industry, there are four domains
of master data:
Master data is any non-transactional information that is considered to play a key
role in the core operation of a business and re-used for multiple purposes

1
2

Products: Harmonised data and definitions to uniquely identify medicinal
product based on regulated information (e.g. marketing authorisation,
packaging and medicinal information)

3

Organisations: Data that comprises of organisation name and location
address data for organisations such as MAH, sponsors, regulatory authority,
manufacturers

4

8

Substances: Harmonised data and definitions to uniquely identify the
ingredients and materials that constitute medicinal product

Referentials: Lists of terms (controlled vocabularies) used to describe
attributes of products e.g. lists of dosage forms, units of measurement,
routes of administration

Introduction to SPOR data services

© EMA 2016

Implementing ISO IDMP through SPOR

(2 of 2)



Four projects have been established to implement services that centralise
management of each of the domains of master data



The four projects are collectively known as SPOR data services:
Substance Management Services
(SMS)

Organisations Management Services
(OMS)

Product Management Services
(PMS)

Referentials Management Services
(RMS)



The implementation of the four SPOR projects will be phased



All proposals relating to implementation of SPOR have been and will continue to
be consulted on widely with regulators and industry representatives



SPOR applies to both domains, Human and Veterinary



In parallel, EMA is implementing the messaging standards developed by Health
Level Seven (HL7), which define a format for the electronic exchange of data
that is compliant with the ISO IDMP technical specifications.
9

Introduction to SPOR data services

© EMA 2016

Use of SPOR in regulatory activities

Use cases i.e. Regulatory activity
dependent on SPOR data

Product
lifecycle

Adoption of SPOR operating models will facilitate the implementation of consistent, centrallymaintained, ISO IDMP-compliant SPOR data, which will feed regulatory activity across the
product lifecycle
Investigational
(Pre-submission)

Authorisation
(Submission)

Postauthorisation
Pharmacovigilance

Clinical Trials
Applications

(as-is via Eudra CT;
to-be via CT Portal)

Marketing
Authorisation
Applications

(as-is via eAF;
to-be via CESSP – H&V)
• CP
• DCP
• MRP
• National
• Referrals

(as-is via eSubmission
Gateway & web client; tobe - tbc)
• PSUR
• ICSR
• ADR
• Maintenance of Art 57

Post-authorisation
Applications
& Referrals
(as-is via eAF;
to-be via CESSP)

eHealth

Falsified
Medicines
Future EU initiatives
that will depend on
SPOR data

Inspections (via Eudra GMDP integrated with SPOR)

Master Data Management

(Substance, Product, Organisation, Referentials)
10

Introduction to SPOR data services

© EMA 2016

Benefits of implementing SPOR
Standardised data alone is not sufficient to achieve benefits. The benefits of SPOR will be
realised incrementally:
• As all phases of SPOR are completed; and
• Provided other opportunities for integration are implemented via EU Telematics Programmes
such as CESSP, Clinical Trials EU Portal
Benefits

Enabled by

Positive impact on public health and safety

Faster, more efficient regulatory action and
decision-making

Better decisions, faster regulatory action

Improved data integrity and reliability through
centrally-held SPOR data

Increase in data quality, simplification of data
management practices

Data reviewed, assessed and approved as part
of the new data operating model

Fulfil regulatory requirements more effectively

Reducing silos and improving interoperability
across EU systems

Operational savings and efficiencies

Data entered only once and reused across
different procedures and regulators

E.g. product recalls, safety information and assessment

11

Introduction to SPOR data services

© EMA 2016

Implementation of SPOR data services

12

Introduction to SPOR data services
© EMA 2016

Key changes as a result of SPOR

.

EMA IT
Service Desk

New ways of
accessing
SPOR data

.

Introduction to SPOR data services

.

EMA Data
Stewards
managing
SPOR data

OMS and RMS
Operating
Models

13

(technical
support for
stakeholders)

.

Data content:
RMS lists and
OMS dictionary

.

Data
management

.

© EMA 2016

Key changes as a result of SPOR

New ways of accessing SPOR data
• SPOR web interface
• SPOR APIs* (Application Programming Interface)
• Draft API specifications have been shared with SPOR
Task Force; final API specifications are expected to be
published in August
• For RMS, backward compatibility will be maintained
with EUTCT for NCAs who use EUTCT
*An API is a mechanism to allow your IT systems to exchange
information automatically with RMS and OMS

14

Introduction to SPOR data services

© EMA 2016

Key changes as a result of SPOR

EMA Data Stewards
• A specialised team of EMA staff that will manage
data on behalf of stakeholders and provide user
support*
• Validate access requests to SPOR services

• Directly involved in maintaining the quality of the
data:
• Profiling the data (assessing quality of data)
• Various data anomalies (different formats of the data
e.g. telephone number) can be identified / monitored
and data correction can be initiated
• Reports generated using this cleansed data will be
more reliable

• Take action on change requests for new/amended
Referential Lists/Terms and Organisation data

15

Introduction to SPOR data services

* PMS and SMS: the level of support that will be provided is still
under discussion
© EMA 2016

Key changes as a result of SPOR

Data content
• RMS lists at go-live:
• Lists from EUTCT (apart from Substance list)
• Lists to support OMS
• Lists for ISO 11239 (Pharmaceutical dose forms,
units of presentation, routes of administration and
packaging) and ISO 11240 (Units of measurement)
• Some lists to support PMS project (e.g. Material)

• Content of the OMS dictionary at go live:
• MAHs: (H+V) CAPs & (H) NAPs
• MAAs: (H+V) CAPs
• MRL applicants (Vet)
• MA & MRL contacts: (H+V) CAPs



16

RMS lists and content of the OMS dictionary will
gradually be expanded. Please see data release
plans on slides 36 and 38

Introduction to SPOR data services
© EMA 2016

Key changes as a result of SPOR

OMS Operating Model




EMA will host the Organisations master data and
will provide access to all stakeholders



Common process which requires Industry to
request organisation registration (or update) with
EMA before regulatory submission



NCAs will also be able to submit change requests
(pre-register) to OMS



Organisation data will be validated by the EMA
Data Stewards and available in a structured
format



17

Establishes a centralised dictionary of
Organisations data to be used as a reference and
in support of EU regulatory activities

Please see slide 36 for OMS operating model

Introduction to SPOR data services
© EMA 2016

Key changes as a result of SPOR

RMS Operating Model


EMA will act as the broker and it will provide Referentials
data services to the EU network




Referentials data maintained by EMA Data Stewards
and available in structured format

EMA will host reference lists from different maintenance
organisations (WHO, EDQM, MSSO, BfArM, etc)


EDQM: maintenance organisation for ISO IDMP 11239
(ph. forms, units of presentation, routes of
administration, packaging)



BfArM: maintenance organisation for ISO IDMP 11240
(units of measurement)




Common process which requires industry and other parties
to request registration of Terms before regulatory
submission



Translations done by NCAs



All organisations need to register legacy & specific terms
with EMA


18

EMA will be a maintenance organisation for new lists where
no maintenance organisation exists

Please see slide 34 for RMS operating model

Introduction to SPOR data services
© EMA 2016

Key changes as a result of SPOR

EMA IT Service Desk
• EMA IT Service Desk will provide technical support
for SPOR data services for all stakeholders
• More details on this will follow nearer go-live

19

Introduction to SPOR data services

© EMA 2016

Key changes as a result of SPOR

Data Management
• Industry will need to synchronise data in their
local systems with RMS and OMS on an ongoing
basis
• In order to reflect changes/updates in SPOR data
in their local systems, Industry may need to
transform their local data to align with ISO/EU
data formats within RMS and OMS:
• Data transformation – change the data
structure e.g. split data fields

• Data enrichment – complete the set of data
e.g. add a new field such as post code

20

Introduction to SPOR data services

© EMA 2016

SPOR Task Force
Together, ISO IDMP and SPOR Master Data (aka SPOR
data services) constitute one of the Telematics
programmes known as the Data Integration
Programme

SPOR within the Telematics Governance

EMA has established a SPOR Task Force (aka ISO
IDMP Task Force) made up of representatives from the
EU Regulatory Network, members nominated by
Industry Associations and other interested parties

EMA MB

SPOR Task Force:
• Responsible for advising on aspects related to
planning, development, implementation and
maintenance of the ISO IDMP standards in the EU
• Deliver recommendations on the implementation
strategy
• The group will also act as a communication channel
to all external stakeholders affected by the
implementation of the ISO IDMP standards in the EU
Sub groups:
• Small working groups of topic experts have been
assigned to support project activities. They present
findings and recommendations back to the SPOR
Task Force for review and final adoption.

HMA

EU Telematics Management
Board

Telematics Enterprise
Architecture Board

IT Directors Executive Committee
IT Directors Group

EU Network Data
Board

SPOR data
services

Data Integration
Programme

SPOR Task Force
Sub groups

Strategic
Tactical

21

Introduction to SPOR data services

Operational
© EMA 2016

High level programme timeline



The focus for 2016 is on the first phase of implementation of SPOR through RMS and OMS



These two services will lay the data foundations for delivery of PMS and SMS



PMS and SMS projects are on hold in order to focus resources on implementing RMS and OMS and while
the ISO standards are being finalised. They are expected to resume towards the end of 2016



In the meantime, the PMS and SMS Sub-Group continues to carry out its business-related preparatory work



The plan for PMS and SMS will be shared at a later stage. The high level timeline for PMS and SMS Iteration
1 is outlined below
The 18 month (12+6) period is the
minimum amount of time required to
undertake these activities and as
such will not be reduced

22

Introduction to SPOR data services

© EMA 2016

Key activities for Industry



1

2

The focus of activity in 2016 relates to preparing for RMS and OMS go-live
Industry own their plans to design, implement, test and deploy changes in alignment with SPOR delivery
timelines
Industry should undertake the following activities in order to provide a better foundation for PMS and for
enforcement of use of RMS and OMS in 2017
Programme
participation

Follow through
on priorities

3

• Engage with programme via Industry Change Liaisons and existing forums eg. SPOR Task Force, Sub
Groups
• Engage with change management activities e.g. communications and training
• Undertake the activities below in order to be ready to actively use RMS and OMS post go-live
• Follow the agreed RMS and OMS operating models post RMS and OMS go-live, which include preregistration and ongoing maintenance of SPOR data

Data mapping

• No OMS mapping is required by Industry prior to OMS go-live
• No RMS mapping is required by Industry prior to RMS go-live.
• Post go-live, Industry should map against new Referentials lists and new OMS dictionary content as it is
published
• Post go-live, Industry should synchronise their local Organisation data against the OMS dictionary and their
local Referentials data against existing RMS lists

Data preregistration

• At OMS go-live, Industry should send requests for new/updated Organisation data relating to MAHs only.
As the dictionary is expanded with other types of Organisation data, Industry will be invited to pre-register
data relating to these new Organisations.
• Post RMS go-live, Industry should send requests for new/updated Referentials prior to submitting an
application

4

5

6

23

Process
change

• Identify all data management processes that will need to be adapted in order to align local data and
synchronise it with RMS and OMS on an ongoing basis

Systems
change

• Identify all impacted systems and architecture that will need to be adapted in order to support the process
changes identified above

Introduction to SPOR data services

© EMA 2016

Focus on Industry data activities
Aug 2016

Sep 2016

Oct 2016

Nov 2016

Dec 2016

Jan 2017

Feb 2017

Mar 2017

RMS
go-live
OMS
go-live
Standardise any free text package descriptions using
the terms in the Containers list from EDQM

Map local Containers data (inc standardised package
descriptions) against existing Container list in RMS

RMS

Update local Referentials data against existing lists in RMS
such as pharmaceutical dose forms, routes of administration,
units of measurement etc.
Map local data against new Referentials lists such as
materials as they are made available
Submit requests for new/updated Referentials terms prior to
submitting applications (pre-registration)
Keep local Referentials data synchronised with RMS

OMS

Submit requests prior to submitting applications
(pre-registration) for new/updated data relating to:
• MAH (NAPs/CAPs)
• MA applicant (CAPs)
• MRL Applicants
Map local data against OMS dictionary at go-live and when
new data becomes available in line with data release plan
Submit requests for new/updated Organisations data prior to
submitting applications (pre-registration)
Keep local Organisations data synchronised with OMS

24

Introduction to SPOR data services

© EMA 2016

Impact on existing submission processes


Future phases of SPOR will deliver beyond 2017 to allow technical and business process
integration of SPOR data with systems developed within other EU Telematics Programmes



RMS and OMS operating models can only be fully enforced once all phases of SPOR have
completed and once other programmes dependent on SPOR data are implemented and
integrated



At go-live, submission processes will continue as before and there will be no immediate
process changes for Industry stakeholders


Some changes in the current submission processes are being explored in relation to
Article 57 (xEVMPD) and Initial MAH application submission



During Q1 2017, it is in the interests of Industry to familiarise themselves with using RMS
and OMS operating models and systems in order to better position themselves for when
their use becomes enforced later in 2017 and for when PMS goes live in 2018



More information will be released in the Autumn to explain any applicable process changes
and timings

25

Introduction to SPOR data services

© EMA 2016

SPOR engagement activity

26

Introduction to SPOR data services

© EMA 2016

The SPOR story so far…
While the impacts of SPOR on Industry stakeholders are not yet being felt, there
is plenty of activity taking place in the background to establish the environment
for uptake of RMS and OMS by Industry post go-live:

2014
Master Data
Management
SPOR started
(mid-2014)

2015
Master Data SPOR
Roadmap finalised
(April 2015)

SPOR Task
Force launched
(March 2015)

27

Introduction to SPOR data services

2016
OMS
implementation
starts (Sep 2015) NCA Change
Liaisons
appointed
(Mar 2016)

RMS
implementation
starts (May 2015)

Extend
involvement in
SPOR to
Veterinary
stakeholders
(Jan 2016)

Implementation
questionnaire to Veterinary
NCAs
webinar
(May 2016)
(Jun 2016)

NCA Change Data mapping Industry Change
Liaisons kick-off
webinar for Liaisons kick-off
(Apr 2016)
NCAs (Jun
(July 2016)
2016)

© EMA 2016

SPOR Change Network
We have established a Change Network to help us broaden the reach of the EMA
in communicating about SPOR. It comprises the following key roles:

Cascade communications material
across Industry in an interactive way
Promote sharing of best practice
Feedback on comms and training
materials and activities





Members

SPOR Task Force members representing
EU Industry Associations (Industry
Association Change Liaisons) and
Vendors (Vendor Change Liaisons)

NCA Change Liaisons

Role

Role

Members

Industry Change Liaisons

Nominees from NCAs

Cascade communications material
with their own organisation and to
their national trade associations,
translating as needed



28



Work with Industry Change Liaisons
to cascade communications material
across Industry

Introduction to SPOR data services

Members

EMA’s established contact points at
EU Industry Associations

SME stakeholder office

Role

Role

Members

Contact points at Industry
Associations (via EMA
stakeholder office)

EMA function that supports SME
stakeholders



Cascade communications material
directly to SME stakeholders that
are registered with EMA

© EMA 2016

Key Industry engagement activities



Industry Change Liaisons will provide a continuous channel for information and training
throughout the year
In addition, a number of specific events are planned that will be open to all Industry
stakeholders
Aug

Sep

Introduction to
SPOR data services
broadcast

Start roll out of
key reference
material on
SPOR public
website

29

Introduction to SPOR data services

Oct

Nov

UAT
completed

Businessrelated training
available

Dec

RMS & OMS
Go Live

Systemsrelated training
webinars
commence

Jan

Feb

Best practice
broadcast

Training videos
published
online

© EMA 2016

Your routes to find out more

Industry Change Liaisons

SME stakeholder office

Industry stakeholders should reach out to the appropriate body within the Change Network as the first
port of call relating to SPOR for:






Information: central communications and key messages
Training: signpost training material and reinforce your understanding
Answering your questions
Receiving your feedback on communications & training activity and content
Supporting the exchange of best practice




See Appendix for list of Industry Associations represented by Industry Change Liaisons



30

We will publish a contact list for Industry Change Liaisons on the SPOR public website

If you are a national trade association you may need to contact your NCA

SPOR public website for
information on SPOR, reference
materials and videos on key
topics:
Navigation route: EMA home >
Data submission on medicines >
Implementation of ISO IDMP
standards

Videos to provide bite-size
chunks of information on key
topics. These are easily digestible
snippets of information (unlike
recorded webinars which can last
up to 3 hrs)

Webinars/Broadcasts to
deliver longer duration live
communications to a large
audience across the EU region in
an interactive, engaging way.
Also provides a forum for Q&A.
Where appropriate, webinars will
be recorded and posted online.

© EMA 2016

SPOR reference material
Technical documentation:

Business documentation:







Roll-out plan for RMS and OMS
Stakeholder engagement
approach
SPOR high level benefits
SPOR high level changes
RMS and OMS operating model
guidance
Expansion timelines of RMS
lists and OMS dictionary





Data mapping guidance for
Referentials and Organisations
RMS and OMS data models
RMS and OMS APIs
specifications

Some of the topics covered in this presentation will be expanded and shared in August
Links will be provided to reference material from the ISO IDMP/SPOR landing page on the
EMA public website
Navigation route: www.ema.europa.eu>Data submission for medicines>Implementation
of ISO IDMP standards

31

Introduction to SPOR data services

© EMA 2016

If you are an SME stakeholder


If you are an SME and are not yet registered with the SME stakeholder office at
EMA, we strongly recommend you to consider registering



The SPOR change team will work with the SME stakeholder office and will use
their established communications channels to disseminate information about
SPOR



As a registered SME, you will be able to keep up to date with SPOR data services
via the SME office



For more information on SMEs and what administrative, regulatory and financial
support is available to companies assigned SME status by EMA, navigate the EMA
website:



32

EMA home>Human regulatory>Supporting SMEs
EMA home>Veterinary regulatory>Supporting SMEs

Introduction to SPOR data services

© EMA 2016

Deep dive: Operating models

33

Introduction to SPOR data services

© EMA 2016

RMS Operating Model

34

NCA Change Liaisons – 26 May 2016

© EMA 2016

Referentials data release plan
Post go-live users should access RMS and subscribe to
be notified whenever a new list has been published

Key
Points at which new Referentials list will
be added
Stakeholders should only start submitting
Change Requests for Referentials once the
data is published in RMS – not before.
RMS go live

RMS Live

Q4 2016

RMS lists at go-live:
• Lists from EUTCT (apart from substance list)
• Lists to support OMS project
• Lists for ISO 11239 (Pharmaceutical dose
forms, units of presentation, routes of
administration and packaging) and ISO 11240
(Units of measurement)
• Some lists to support PMS project (e.g.
Material)

35

Introduction to SPOR data services

Further lists to support
PMS and SMS to be
included as and when
available

© EMA 2016

OMS Operating Model – Phase I
Phase I - Organisations Operating Model – Implemented as part of the first OMS project
Scenario applicable when the regulatory submission takes place with an NCA

Industry

Pre-Registration of Organisation in the EU
Organisation Hub

Applications/information sent as part of regulatory activities

Request
Organisation
registration or
update

Submit application

Message containing:



etc.

NCA_org_ID &
EU_Loc_ID and
organisation data
(& other IDs)

NCA

If not registered, assign
NCA_org_ID and validate
against EU_Loc_ID

Request for
organisation
registration or
update

EU_Loc_ID and organisation data (& other IDs)

EMA

EU_Loc_ID and
organisation data (&
other IDs)

Register and issue
EU_Loc_ID & Org_ID

Request for
organisation
registration or
update
MDM (EU Hub)

36

Introduction to SPOR data services

Publish data in the
organisation dictionary

© EMA 2016

Organisations data release plan
EMA will issue advance communications to notify all
stakeholders that new data is being published on OMS
and that Change Requests for that data can be
submitted now that it has been published on OMS (not
before).

Key
Points at which new organisation data is
published in OMS
Industry should only start submitting Change
Requests for Organisations once the data is
published in OMS – not before.
OMS go live

OMS
Go live

Q4 2016

Q1 2017

Q3 2017

Q4 2017

2018 / 2019
TBD: CROs; CT site;
Academia;
Hospitals;
Distributers etc.

• MAHs: (H+V) CAPs & (H) NAPs
• MAAs: (H+V) CAPs
• MRL applicants (Vet)

37

Sponsors

Introduction to SPOR data services

Regulatory
Authority
/NCAs

Manufacturers:
(H+V) CAPs

Manufacturers:
(H+V) NAPs

© EMA 2016

Operating Model advantages




SPOR data is a single and trusted source of data



Common process which requires industry and other parties alike to request
registration of Referentials and Organisations data before regulatory submission



Common process to request changes to the OMS dictionary and to Referentials
lists/terms



Referentials and Organisation data validated by the EMA Data Stewards and available
in a structured format



Establishes a complete and high quality dictionary of Organisations and lists of
Referentials terms to be used as a reference and in support of EU regulatory activities



38

SPOR data is hosted by EMA, accessible to and used throughout EMA and by external
stakeholders

Single format and simplified process to consume Referentials lists and keep them
updated

Introduction to SPOR data services

© EMA 2016

RMS and OMS Services
The use cases and operating models for SPOR require stakeholders to interact with SPOR data. To support these
interactions, stakeholders will be able to make use of SPOR data services:
Customer support

RMS & OMS
• Customer support: business/technical queries; issues; training
• All users authenticated & authorised
Browse data

RMS
• List of lists
• List of terms incl. Term Summaries &
Term details
OMS
• List of organisations with location
addresses
• All Org_IDs and Org_Loc_IDs
Search

RMS
• Standard and advanced search (UI)
• Google-style search (API)
• Lists and terms
• Historical versions (date/version
number)
• OID for sources of information
• Language(s)
• Applicability
OMS
• Standard search
• Org and Location data
• Historical versions (date/time stamps)
• Based on source system/other IDs
(e.g. EV_Code, DUNS/GTIN, etc)
RMS & OMS
• View & Publish documents
39

Change requests

RMS
• Search
• Read
• New/update/delete Term Request
• New/update List Request
• Document attachments
OMS
• Read
• Create/Update Org/Location
• Add location
• Document attachments
Export

RMS
• List of lists
• List of terms
• Full list or set of results
• Filter By Languages
OMS
• Full dictionary or set of results
• File contains: all versions, Org name
and location address in all languages,
source system IDs, international
organisation identifiers, etc

Multi-lingual

OMS
• Organisation name
• Location addresses
Term Translations

RMS
• Search
• Read/ Update

ID Translation Service

RMS
• Source term ID into RMS ID
Saved queries

RMS
• Search queries
• Crate/update/delete queries
Tags

RMS
• Search
• Create/Update/Delete

Subscriptions

RMS
• Search
• Create/Update/Delete

Documents

© EMA 2016

Key contacts

40

Introduction to SPOR data services

© EMA 2016

Industry Change Liaisons



These are the Industry Associations represented by Industry Change Liaisons.
A contact email address for each Industry Association will be published on the SPOR public
website, which will be monitored by Industry Change Liaisons in order to provide you with
a dedicated channel for queries relating to SPOR.

Association of the European
Self-Medication Industry

European Group for Generic
Veterinary Products

EuropaBio

EuroPharm SMC

European Biopharmaceutical
Enterprises

Eye-Care Industries – European
Economic Interest Grouping

European Confederation of
Pharmaceutical Entrepreneurs

International Federation for Animal
Health Europe

European Federation of Pharmaceutical
Industries and Associations

Medicines for Europe

European Federation of Statisticians in
the Pharmaceutical Industry

Vaccines Europe

41

Introduction to SPOR data services

© EMA 2016

NCA Change Liaisons
These are the NCAs represented by NCA Change Liaisons. If you need to contact your NCA regarding SPOR,
please use the general information contact address provided by that NCA.
Country

Organisation

Country

Organisation

Austria

Austrian Medicines and Medical Devices
Agency (AGES-MEA)

Latvia

State Agency of Medicines (ZVA)

Belgium

Federal Agency for Medicines and Health
Products (FAMHP)

Liechtenstein

Office for Public Health

Bulgaria

Bulgarian Drug Agency (BDA)

Lithuania

Croatia

Agency for Medicinal Products and Medical
Devices of Croatia (HALMED)

Cyprus

Department of Information Technology
Services (DITS), Ministry of Health
Veterinary Services - Ministry of
Agriculture, Rural Development and
Environment

Czech Republic

State Institute for Drug Control (SÚKL)

Denmark

Estonian State Agency of Medicines (SAM)

Finland

Ministry of Health Luxembourg

Malta

Medicines Authority Malta

Netherlands

Medicines Evaluation Board (CBG-MEB)

Norway

Norwegian Medicines Agency (NoMA)

Finnish Medicines Agency (FIMEA)

France

National Drug and Health Products Safety
Agency (ANSM)
French Agency for Veterinary Medicinal
Products (Anses-ANMV)

National Authority of Medicines and Health
Products, IP (INFARMED)

Portugal

Romania
Slovak Republic

Paul-Ehrlich-Institut

Germany

Hungary

Federal Institute for Drugs and Medical
Devices (BfArM)
Directorate of Veterinary Medicinal
Products, National Food Chain Safety Office
(NFCSO - NEBIH)
National Institute of Pharmacy and
Nutrition (OGYEI)

Iceland

Icelandic Medicines Agency (IMA)

Ireland

Health Products Regulatory Authority
(HPRA)

Italy

State Medicines Control Agency (SMCA VVKT)

Luxembourg

Danish Medicines Agency (DKMA)

Estonia

National Food and Veterinary Risk
Assessment Institute (VET)

Portuguese National Authority for Animal
Health, Directorate General of Food and
Veterinary (DGAV (DGAMV))
National Agency of Medicines and Medical
Devices (ANM)

Slovakian Medicines Agency - State
Institute for Drug Control (SUKL)
Institute for State Control of Veterinary
Biologicals and Medicaments

Slovenia

Agency for Medicinal Products and Medical
Devices (JAZMP)

Spain

Spanish Agency of Medicines and Medical
Devices (AEMPS)

Sweden

Medical Products Agency (MPA)

UK

Medicines & Healthcare products
Regulatory Agency (MHRA)

Italian Medicines Agency (AIFA)

42 Introduction to SPOR data services

Veterinary Medicines Directorate (VMD)

© EMA 2016
(as at 5 May 2016)

In summary

43

Introduction to SPOR data services

© EMA 2016

In summary

SPOR data services: Delivering quality data services on Substances,
Products, Organisations and Referentials to power EU regulatory activities



SPOR data services will act as the vehicle for implementation of ISO IDMP
standards



SPOR data services will enable the realisation of benefits at all stages of the
product lifecycle due to future integration of regulatory processes with SPOR’s
standardised data and central data management services



Implementation of RMS and OMS is the first step in a phased approach to roll-out
of SPOR and of other Programmes dependent on SPOR data



In order to be ready for the future changes brought about by SPOR and by
integration with other Programmes, Industry should prepare now to ensure they
have the foundations in place through alignment with RMS and OMS

44

Introduction to SPOR data services

© EMA 2016

Glossary

45

Introduction to SPOR data services

© EMA 2016

Glossary
API

Backward
compatibility

Capability of a new solution to successfully interface/work with previous versions of
software/hardware

CESSP

The Common European Single Submission Portal (CESSP) is an ongoing Telematics
programme that aims to integrate the electronic Application Form (eAF) data sets in to
CESP. CESP is the current submission channel for all procedures (not technically
integrated with eAF)

Change
Network

A collection of representatives from Industry and regulators with responsibility for acting
as the central contact point for Industry stakeholders in relation to SPOR data services.

Controlled
vocabularies

(aka Referentials) are lists of terms that refer to attributes of medicinal and
pharmaceutical products e.g. dosage form, route of administration, unit of measurement

CT Portal

(aka EU Portal and Database) will be the upgraded version of Eudra CT enabling a
single entry point for submission and assessment of clinical trial applications at an EU
level

eAF

The eAF is a collection of Application Forms that facilitate electronic submission of data
relating to Renewals, Variations, Marketing Authorisation Applications (Human & Vet)

Eudra CT
46

Application Programming Interface is a set of programming instructions and standards
for accessing a Web-based software application or Web tool

The existing platform for submitting and viewing information relating to regulatory
activities relating to Clinical Trials

Introduction to SPOR data services

© EMA 2016

Glossary
Eudra GMDP

EUTCT

A repository and provider of controlled terms (or controlled vocabularies) in multiple
languages. It is the predecessor of RMS. RMS will replace EUTCT with regards to
management of controlled vocabularies. EUTCT can only be fully replaced after SMS
implementation as it also contains substances

HL7

Health Level Seven (HL7) is a set of messaging standards that defines the format for the
electronic exchange of data that is compliant with ISO IDMP technical specifications

Master data

Any information that is considered to play a key role in the core operation of a business
and is re-used for multiple purposes

Unique
identifiers

47

EMA database that includes information relating to Manufacturing and Distribution good
practice supporting coordination and output from Inspections activities

The ISO IDMP standards outline a set of attributes/data elements that make up a
unique identifier . This enables the creation of a unique record for each medicinal
product, packaged product, pharmaceutical product, substance and referential

Introduction to SPOR data services

© EMA 2016

Thank you for your attention
Further information
Please send any queries for the change team to:
SPOR-Change-Liaisons@ema.europa.eu
European Medicines Agency

30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom
Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555
Send a question via our website www.ema.europa.eu/contact

Follow us on

@EMA_News
© EMA 2016

Disclaimer
The EMA SPOR change team aims to disseminate material about SPOR through established communication channels. The EMA
SPOR change team's goal is to keep this information and material timely and accurate. If errors are brought to its attention,
the EMA SPOR change team will try to correct them.
The European Medicines Agency accepts no responsibility or liability whatsoever (including, but not limited to, any direct or
consequential loss or damage that might occur to you and/or any other third party) arising out of, or in connection, with the
information disseminated through these communication channels. In particular, the Agency is indemnified from and against all
costs, proceedings, claims, expenses and liabilities whatsoever arising from any breach by any legal or natural person as a
result of any representation or warranty providing to be a misrepresentation.
Copyright and limited reproduction notices
The material disseminated through the communication channels can be in the format of a text document (e.g. MS Word or
PdF), a presentation document (e.g. PowerPoint) or an audio or video recording.
The contents of this material are © EMA 2016, with the exception of the material (or parts thereof) where the copyright is
vested in a third party.
The information made available by the EMA SPOR change team may be reproduced and/or distributed, totally or in part,
irrespective of the means and/or the formats used, for non-commercial purposes only, without prior permission, provided that
the respective copyright holder is always acknowledged as the source of the material. Such acknowledgement must be
included in each copy of the material.

Contact
You can contact the EMA SPOR Change team at: SPOR-Change-Liaisons@ema.europa.eu

© EMA 2016