About creating value beyond IDMP compliance by connecting information silo's.

1. IDMP: Creating value beyond
compliance by connecting
information silo’s
Michiel Stam
Regulatory Operations Consultant
eCTDconsultancy B.V.

2. Presentation outline
• Current challenges
• Interoperability
• Solutions
• Value
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3. Information stored across different systems
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4. Communicated in different formats at different stages in
the product life cycle
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5. Duplication of information across data stores
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6. Out-of-sync information and (lack of) complex system
integrations
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7. Confusion due to multiple versions of the truth!
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8. Lack of horizontal process integration
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Clinical Supply chain Regulatory

9. 60-80% of the data for IDMP exists in documents only..
• Life Cycle Management & content control
• Laborious to retrieve and extract data
• “Free text” or natural language
• Semantic challenges
• Maintenance & Validation extracted data
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10. Challenges related to structured data and systems
• Custom data models, often in tabular format
• Data stored different formats, often free text
• High dependency on back end IT development
• Enabling connectivity
• Method for resolving identity?
• Meaning of information elements across the sources?
• How to deal with differing data models and relational databases?
(= information derives meaning from the context and location of storage)
• Data Quality
• Semantic challenges
• Data stored according to different terminologies
• Dictionaries not equally defined
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11. IDMP: Interoperability challenge
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Organizational
Interoperability
Semantic
Interoperability
Technical
Interoperability
Standards Terminology
Meaning Languages
Laws Policies
Cooperation agreements Workflows
Transport protocols Data security
Data accessibility
Services and messages
Data accessibility
Data integrity
Too often forgotten!

12. “Concept” or “Unit of thought”
• Impact on information retrievability and coding
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Prolonged-
release tablet
Extended-
release tablet
Tablet met
verlengde
afgifte
PDF-10226000
PHF00212MIG

13. Natural language
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Prolonged-
release tablet
Extended-
release tablet
Tabletten met
verlengde
afgifte
PDF-
10226000
PHF00212MIG
Prolonged-
release
tablets
Prolonged-
releese tablet
Tablets,
prolonged
release

14. Same term for multiple concepts in the same CV
• EDQM: Modified-release tablets include prolonged-release, delayed
release and pulsatile-release preparations
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Pulsatile-release tablet
Modified release tablet
Prolonged-release tablet
broaderbroader
Delayed-release
tablet
broader

15. IDMP: Value Beyond Compliance ©eCTDconsultancy 15
What could
possibly go
wrong?

16. Potential Solutions
Challenge Solution
Unstructured data Entity extraction
Structured Authoring
Structured data siloes and process
siloes
Master Data Management
Linked Data
Semantic challenges Reference Data Management
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17. Entity extraction or “text mining”
• Unstructured  Structured
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18. Entity extraction by Text Mining
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19. Text extraction techniques
• Reference vocabularies
• Business rules and regular expressions
• NLP algorithms
• Sensitivity vs Specificity!!!
“How good at finding something if it's there”
“How accurate against false positives”
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e.g. “Can”

20. From unstructured to structured data using text mining:
study SmPC section 4.8 ADR
• The baseline algorithm provided MedDRA matches for 87% of the
unique terms listed in SPCs of 75 CAPs.
• The incorporation of additional synonyms and spelling variations (e.g.
“a” vs. “ae”) increased the hit rate to 98% on an independent test set
of 169 CAPs.
• Fuzzy text matching led to a substantial performance gain in
extracting MedDRA terms from European SPCs.
Source: Bergvall et al. Pharmacoepidemiol Drug Saf. 2011;20(S1), S143.
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21. Structured Authoring
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22. Tagging concepts
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Building Blocks
[ATC Code]
[Invented Name]
[Units of Presentation]
[Dose Form]
[Packaging]
MDM
[ ]
[ ]

23. Master Data Management
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MDM is a is a single source of common business data used
across multiple systems, applications, and/or processes.
MDM is a discipline for specialized quality improvement,
defined by the policies and procedures put in place by a data
governance organization,

24. Example MDM Architectures
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25. Master Data Management & resolving data identity
• Example: “Approved” versus “Implemented” Shelf Life
• Manufacturing (e.g. SAP): 3 years
• Regulatory (e.g. SmPC): 5 years
Definition and context of the term “Shelf Life”??
Owned by??
Required for IDMP?
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26. Reference Data Management
Reference Data is the data used to categorize other data within
applications, databases and documents
• Define the set of permissible values used in other fields
• Hierarchy management between concepts within the same
terminology
• Manage various external terminologies covering the same concepts
(and create crosswalks between shared concepts)
• Associate non-preferred labels (terms) with concepts
• E.g. for deprecated terms or spelling errors
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27. Shared concepts and crosswalks across
terminologies
IDMP: Value Beyond Compliance© 2014 DIA, Inc. All rights reserved.

28. RDM & the role of Data Steward
• Manage internal- and external CVs
• Profile external maintenance organisation
• E.g. subscriptions, fees
• Maintenance processes
• Monitor updates (e.g. periodic, ongoing)
• Versioning, audit trail etc.
• Mapping and validation by SME
• Distribution
• Technical ((Push or pull, Automated or manual, REST (real-time), XML/RDF)
• Responsible, Accountable, Consulted and Informed?
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29. Linked data: “from a web of documents to a web of data”
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Link data like documents are linked
Information is stored and retrieved using
URI’s: http://whocc.no/atc#A12BA01
A set of best practices for publishing
and connecting structured data
Model data in RDF: a generic
graph-based model to structure
and link data that describes things
in the world

30. RDF – Resource Description Format
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ObjectSubject
Predicate
BlueT-shirt
has color

31. RDF – Resource Description Format
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hasATC
Prednisone
same As
Adasone
Adasone A07EA03
Prednisone A07EA03
hasATC

32. SKOS labels for predicates of CV’s
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skos:broader
Modified
release
tablet
skos:broaderExtended
release
tablet
Prolonged
release
tablet
Modified
release
tablet
Extended
release
tablet
Prolonged
release
tablet
skos:exactMatch
EDQM
SPL
Crosswalk

33. Ontology (knowledge graphs) to
describe data models
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34. SKOS as Linked data URI’s
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https://idmp.eu/hasATChttp://ginas.ca/s
ubstance#Adaso
ne
http://whocc.no
/atc#A07EA03
All data has a unique “URI”
(address):
- Data = data
- Metadata = data
- Data model = data

35. Open Linked Data vs. Private Linked Data
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OpenFDA provides structured
datasets including:
- adverse events
- drug product labeling
- recall enforcement reports
first innovation created by Taha
Kass-Hout, MD, MS, upon joining
FDA as the first Chief Health
Information Officer in March 2013.

36. Linked Data: openFDA SPL data
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37. Needle in the Haystack & Semantic Web Stack
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- Getting all data in one place
- classifying the information in the haystack
well enough to facilitate finding the needles

38. Value beyond compliance?
• Transparency
• Clear data ownership and responsibilities
• Risk reduction
• Efficiency
• De-duplication of data
• Process optimization
• “What is the current status of…?”
• Collaboration
• Cost?
• E.g. IT infrastructure and software licenses
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39. Thank you!
Questions??
Michiel Stam
Regulatory Operations Consultant
mstam@ectdconsultancy.com
0031610536922
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