Bundesamt für Sicherheit im Gesundheitswesen · ISO/TS 19844:2016 • Health informatics --...
Transcript of Bundesamt für Sicherheit im Gesundheitswesen · ISO/TS 19844:2016 • Health informatics --...
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Bundesamt für Sicherheit im Gesundheitswesen
www.basg.gv.at
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Georg Neuwirther Head of IT Austrian Medicines and Medical Devices Agency
IDMP & SPOR @ AGES Gespräch 11/2017
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Georg Neuwirther 3
Motivation 1 Data-Exchange of Information about Medicinal Products in Europe (and worldwide)
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Motivation 2 Good data quality supports all processes in pharmacovigilance (and other
regulatory activities)
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Motivation 3 Cross-Border ePrescription
Source: EMA
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Georg Neuwirther 6
Enable an European product database
Support handling of shortages
Support processing recalls
..
..
Motivation 4 Further examples
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Issue 1: lack of standardisation
• Different controlled vocabularies* are
used across different NCAs
• Names used for organisations differ
between, and sometimes across
different departments within, NCAs
• Different names for products and
substances are used across different
NCAs
• Data is often entered manually
• 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 are
lists of terms that refer to
attributes of medicinal and
pharmaceutical products eg.
dosage form, route of
administration, unit of
measurement
Not an issue if you work separately but if you want
to collaborate with others
e.g. EudraPharm Vet, eMedikation, .. Source: EMA
Georg Neuwirther
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Similar information stored in several places
• e.g. organisations
• e.g. centralized products
Different formats, different ways of entering same information
Issue 2: No shared databases
Georg Neuwirther
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Legal Background
COMMISSION IMPLEMENTING REGULATION (EU) No 520/2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of
the Council and Directive 2001/83/EC of the European Parliament and of the Council
CHAPTER IV Use of terminology, formats and standards
Article 25 Use of internationally agreed terminology
1. For the classification, retrieval, presentation, risk-benefit evaluation and assessment, electronic exchange and communication of
pharmacovigilance and medicinal product information, Member States, marketing authorisation holders and the Agency shall apply
the following terminology …
EMA Website http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001849.jsp
“Commission Implementing Regulation (EU) No 520/2012 (articles 25 and 26) obliges European Union (EU) Member States,
marketing authorisation holders and EMA to make use of the ISO IDMP standards. This will impact on many areas of the
pharmaceutical regulatory environment, both in the EU and other regions. ”
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provide tools to share common information
Overview IDMP & SPOR
• standardise all relevant datafields
IDMP - Identification of Medicinal Products
SPOR – shared data for Substances, Products, Organisations, Referentials
• Provide shared repositories for substances, products,
organisations, referentials
• Provide controlled terms
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Georg Neuwirther
IDMP Identification of Medicinal Products
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ISO IDMP
• The ISO IDMP standards establish definitions and concepts and
describe data elements and their structural relationships that are
required for the unique identification of:
• Medicinal product information (MPID/PCID)
- ISO 11615
• Pharmaceutical product information (PHPID)
- ISO 11616
• Substances (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 developmental
medicinal products for Human and Veterinary use
Source: EMA
Georg Neuwirther 12
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Standard 11615
ISO/TS 20443
• Health informatics -- Identification of medicinal products -- Implementation guidelines for ISO 11615
data elements and structures for the unique identification and exchange of regulated medicinal
product information
Standard 11616
ISO/TS 20451
• Health informatics -- Identification of medicinal products -- Implementation guidelines for ISO 11616
data elements and structures for the unique identification and exchange of regulated
pharmaceutical product information
Status standards and technical specifications
Georg Neuwirther 13
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Standard 11238
ISO/TS 19844:2016
• Health informatics -- Identification of medicinal products -- Implementation guidelines for data
elements and structures for the unique identification and exchange of regulated information on
substance
Status standards and technical specifications
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EU implementation Guideline
Status standards and technical specifications In progress
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IDMP Scope
Source: EMA - Introduction to ISO Identification of MedicinalProducts, SPOR programme
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Business
• Semantic descriptions (harmonised) of all relevant datafields
• e.g. reference strength
• Data formats, Controlled Terms usage
• Business rules
• Business Processes?
Technically
• Database models have to be refactored
• User interfaces must be updated
• Reporting could look different
• ….
IDMP consequences Impact on Business and IT
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Article 57
• XEVPRM, XEVMPD
• but no concrete plans currently available
ICSRs
“… as a consequence of the legal requirements set out in the legislation, the xEVPRM will be
replaced by the ISO IDMP format E2B(R3) …” (Source: Introduction to ISO Identification of MedicinalProducts, SPOR programme)
Further IDMP consequences
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IDMP will introduce a set of new IDs
IDs are needed for interoperability
and the business cases (e.g. PHV)
IDMP related IDs will be additional
to current IDs like authorization numbers
IDMP will introduces a set of new IDs
Medicinal Product
MPID
Medicinal
Product
Manufacturer
Marketing
Authorisation
Packaged
Medicinal Product
PCID
Pharmaceutical
Product
PhPID
Clinical
Particulars
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Example Pharmaceutical Product
Georg Neuwirther 20 Source: EMA
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MPIDs according to the standard could be to unstable for usage
• on MAH change
• on legal status of supply change
• on indications
PHPID (pharmaceutical product)
• There are several levels of pharmaceutical products a lot of IDs
a) Level 1: Substance(s)
b) Level 2: Substance(s) / Strength / Reference Strength
c) Level 3: Substance(s) / Administrable Dose Form
d) Level: Substance(s) / Strength / Reference Strength/ Administrable Dose Form
First impression
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22 Georg Neuwirther 22
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SPOR
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IDMP: set of standards and technical specifications defining the model of medicinal
products and substances
• no data; only documentation
SPOR: master data management
• SPOR-services will be provided and hosted by EMA
• contains and provides data
• based on IDMP standards
IDMP vs. SPOR
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1. Implement an integrated and harmonised master data management (MDM) solution which
will deliver standards compliant master data for Substances, Products, Organisations and
Referentials (SPOR).
2. Data will be collected, managed and made available to the network, industry and wider
stakeholder community, in compliance with legislative requirements and relevant standards
for privacy, data protection and security.
3. Implement a new portfolio of services which will be supported by standardised data
governance and lifecycle management.
4. Maximise the benefits realised throughout the Implementation f the roadmap by involving
and engaging effectively with stakeholders, leading to operating model simplification and
efficiency
Goals of SPOR Master data management MDM
Source: European Medicines Agency (EMA) Master Data Management Roadmap
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SPOR
Product Data
Referentials Common terminologies , building blocks
for product and substance data set .
Product European database of products for
human and veterinary medicines .
Substance
Single source of substance information
for the network .
Organisation Unique European identifier for
organisations e.g. Marketing
authorization holders , manufacturers
Source: EMA
online
online
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Substances – SMS
• active substances, excipients and adjuvant
• plan to build up an European Expert team
Substance are the core element for IDMP / pharmaceutical products and calculation of IDMP-IDs
To build a comprehensive list of substances in EU with a harmonised definition, supported by an
standardised data exchange model, available in an easily accessible format aimed to power business
and regulatory processes in EU and at global level. As adopted by EU ISO IDMP Task Force
12 June 2015
Georg Neuwirther
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Georg Neuwirther 28
Provides a medicinal product databbase set to support regulatory activities
for both human and veterinary domains - based on RMS, SMS and OMS
Products – PMS
This will be the core of our common European medicinal product database!
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PMS - being more concrete … – NOT APROVED – only for illustration
Source: EMA website, EUNDB - – 19 February 2016 Georg Neuwirther 29
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Referentials - RMS
• Pharmaceutical forms
• Routes of
Administration
• Units of measure
• ATC codes
Examples
• EDQM
• EMA
• ISO
• WHO
• MSSO
Providers
To provide a single, trusted source of referentials data to be used across the EU Regulatory Network
and Pharmaceutical Industry, with consistent and well-understood mechanisms to update and
consume referentials lists
Georg Neuwirther
We are used to that, aren’ we – EUTCT?
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ONLINE: https://spor.ema.europa.eu/rmswi/#/
RMS
Georg Neuwirther 31
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RMS – Lists of controlled termin Currently 109 lists available
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https://spor.ema.europa.eu/
Login needed (see also later)
Use Case: eAF!
RMS - requesting new terms or updates
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RMS / 3 Change Requests
Georg Neuwirther 34
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RMS - documentation
Georg Neuwirther 35
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Organisations – OMS
• Marketing Authorisation Holders
• Manufacturing sites
• Regulatory Authorities
• Applicants
• Clinical trial sites
Examples
To provide a consolidated source of high-quality and standardised organisation data to be used
across the EU Regulatory Network, that can support all regulatory activities.
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Georg Neuwirther 37
OMS – Organisation Management Service Scope
“Only” Names and Addresses – no yellow page
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OMS - basic concept for organizations
Org A Org B
Loc 3 Loc 2 Loc 1 Loc 4
Org_ID_A
Org_Loc_ID_1
Org_ID_B
Org_Loc_ID_4 Org_Loc_ID_2 Org_Loc_ID_3
Rules for unique organisations: • All location addresses in the same country • Organisation name is unique for all organisations in the same country.
DE UK
Note: Org A name can be the same as Org B name.
Source: EMA
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OMS
• Link: https://spor.ema.europa.eu/omswi/#/searchOrganisations
• No login needed!
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OMS – Roll Out
Georg Neuwirther 40
Source: EMA, https://spor.ema.europa.eu/omswi/#/viewDocuments, RMS and OMS - Industry on-boarding to SPOR
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https://spor.ema.europa.eu/omswi/#/viewDocuments
OMS – Documentation
Georg Neuwirther 41
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RMS & OMS
User Credentials
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OMS & RMS User Registration
Source: EMA, https://spor.ema.europa.eu/omswi/#/viewDocuments, RMS and OMS - Industry on-boarding to SPOR
Georg Neuwirther 43
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OMS & RMS User Roles
Source: EMA, https://spor.ema.europa.eu/omswi/#/viewDocuments, RMS and OMS - Industry on-boarding to SPOR
Georg Neuwirther 44
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OMS & RMS Super User
very similar to our eServices
Admin can mantain further userss
Source: EMA, RMS and OMS - Industry on-boarding to SPOR
Georg Neuwirther 45
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OMS & RMS Handling multiple organisations
Georg Neuwirther 46 Source: EMA, RMS and OMS - Industry on-boarding to SPOR
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OMS & RMS Even complex scenarios should be possible
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Source: EMA, RMS and OMS - Industry on-boarding to SPOR
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OMS & RMS 1st super user
Georg Neuwirther 48 Source: EMA, RMS and OMS - Industry on-boarding to SPOR
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OMS & RMS Registration Systems required for
Georg Neuwirther 49
servicedesk.ema.europa.eu
EMA‘s service desk for issues, registrations, tickets, etc.
https://register.ema.europa.eu/identityiq/login.jsf
Login to SPOR
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OMS & RMS Registration 1st Super User verification
Georg Neuwirther 50
Source: EMA, RMS and OMS - Industry on-boarding to SPOR
![Page 51: Bundesamt für Sicherheit im Gesundheitswesen · ISO/TS 19844:2016 • Health informatics -- Identification of medicinal products -- Implementation guidelines for data elements and](https://reader033.fdocuments.in/reader033/viewer/2022050110/5f4805b2c03cf358c02351e2/html5/thumbnails/51.jpg)
OMS & RMS Registration 1st Super User verification
Georg Neuwirther 51
Source: EMA, RMS and OMS - Industry on-boarding to SPOR
![Page 52: Bundesamt für Sicherheit im Gesundheitswesen · ISO/TS 19844:2016 • Health informatics -- Identification of medicinal products -- Implementation guidelines for data elements and](https://reader033.fdocuments.in/reader033/viewer/2022050110/5f4805b2c03cf358c02351e2/html5/thumbnails/52.jpg)
OMS & RMS Registration 1st Super User verification
Georg Neuwirther 52
Source: EMA, RMS and OMS - Industry on-boarding to SPOR
![Page 53: Bundesamt für Sicherheit im Gesundheitswesen · ISO/TS 19844:2016 • Health informatics -- Identification of medicinal products -- Implementation guidelines for data elements and](https://reader033.fdocuments.in/reader033/viewer/2022050110/5f4805b2c03cf358c02351e2/html5/thumbnails/53.jpg)
OMS & RMS Registration Documentation
Georg Neuwirther 53
Source: EMA, RMS and OMS - Industry on-boarding to SPOR
![Page 54: Bundesamt für Sicherheit im Gesundheitswesen · ISO/TS 19844:2016 • Health informatics -- Identification of medicinal products -- Implementation guidelines for data elements and](https://reader033.fdocuments.in/reader033/viewer/2022050110/5f4805b2c03cf358c02351e2/html5/thumbnails/54.jpg)
OMS & RMS SLAs
Georg Neuwirther 54
Source: EMA, RMS and OMS - Industry on-boarding to SPOR
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RMS & OMS Milestones
Georg Neuwirther 55 Source: EMA, RMS and OMS - Industry on-boarding to SPOR
Source: EMA, RMS and OMS - Industry on-boarding to SPOR
![Page 56: Bundesamt für Sicherheit im Gesundheitswesen · ISO/TS 19844:2016 • Health informatics -- Identification of medicinal products -- Implementation guidelines for data elements and](https://reader033.fdocuments.in/reader033/viewer/2022050110/5f4805b2c03cf358c02351e2/html5/thumbnails/56.jpg)
Georg Neuwirther 56
Register Super Users (from December)
Get familiar with RMS controlled terms
• Check your RIMs for compatibility – consider mapping
• Request new terms or updates if needed
Check your OMS data once available
Check EMA and BASG website for further
information
• Especially for PMS and SMS plans
Attend EMA webinars and AGES Gespräche!
• Get in contact with your associations
Register at the SME office for newsletter
• Link
Take home messages SPOR
Source: EMA, RMS and OMS - Industry on-boarding to SPOR
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BASG -
Austrian Federal Office for Safety in Health Care
www.basg.gv.at
Traisengasse 5
1200 Vienna
Head of IT Austrian Medicines and Medical Devices Agency
Georg Neuwirther
![Page 58: Bundesamt für Sicherheit im Gesundheitswesen · ISO/TS 19844:2016 • Health informatics -- Identification of medicinal products -- Implementation guidelines for data elements and](https://reader033.fdocuments.in/reader033/viewer/2022050110/5f4805b2c03cf358c02351e2/html5/thumbnails/58.jpg)
Bundesamt für Sicherheit im Gesundheitswesen
www.basg.gv.at