idmp and rim: friend or foe?
TRANSCRIPT
IDMP and RIM: Friend or Foe?
Hans van Bruggen / Michiel Stam
eCTDconsultancy B.V.
Friend or Foe?
IDMP
RIM
Welcome, make
yourself at home!
And clean my kitchen..
Regulatory Information Management
“the collection and management of information from one or more sources…
1
…and the distribution of that information to one or more audiences
IDMP and perspectives on definition of a drug in Pharmaceutical Industry
PV/ Clinical Manufacturing Regulatory Affairs
Was that dose
registered for this
indication?
How and where was the drug
procuded?
What drug,
dose and patient?
Can this Adverse Event be
attributed to a drug?
Agency
Need for a common harmonised definition of “a drug”
Identification of CounterfeitIdentify real batch ID’s for a product
Alternative medication (e.g. drug shortages)Identify alternative sources for the same product
RecallsEasy identification of related/similar products
Improve quality of safety data accuracyIdentification of labelled eventsIdentification of off label use of products
Additional benefits
ISO IDMP
IDMP Structured Data Model
20131114 Get ready for global ISO IDMP 7
Substance Definition
Pharmaceutical Product
Clinical Particulars
Medicinal Product
Marketing Authorization
Manufactured / Establishments
Packaged Medicinal Product
IDMP Classes
1
20131114 Get ready for global ISO IDMP 8
SSID
PhPID
Clinical Particulars
MPID
Marketing Authorization
BAID1/BAID2
PCID
IDMP Identifiers
Age Age Range Contra-indication Disease Status Gender Health Status Specifics Indication Intended Effect Interactant Code System Interaction Effect Interaction Incidence Interaction Type Race Symptom / Condition / Effect Classification Therapy Relationship Type Undesirable Effect
20131114 Get ready for global ISO IDMP 9
Clinical Particulars – Controlled vocabulariesAge
Age Range Contra-indication
Disease Status Gender
Health Status Specifics Indication
Intended Effect Interactant Code System
Interaction Effect Interaction Incidence
Interaction Type Race
Symptom / Condition / Effect Classification Therapy Relationship Type
Undesirable Effect
IDMP Controlled Vocabularies
Common Structured Product definition
A Packaged Product
authorized by an agency in a
country
for use against approved
indications
to be manufactured as
approved
And sold with approved trade
names
on the basis of versioned regulatory
documents
PI
Oral Tablet consisting of Paracetamol 200 mg per Tablet
Box with 2 Blisters of 10 Tablets each
Pharmaceutical Dose Form
Route of Admin
Packaging Type
ISO 11239
Unit of Measurement
ISO 11240
Pharmaceutical Product ISO 11616
Authorized Medicinal Product ISO 11615
Packaged Medicinal Product
ISO 11615
Unit of Presentation
SubstanceISO 11238
Paracetamol,Chemical substance,
USP grade,Manufactured in XYZ
Source: Wim Cypers, ArigGlobal
Source data, data container and data output
1PI
RIM System
CMC/Supply chain/ Labeling
System
PV System
eDMS
RIM System
RA-CMC/ Manufacturing
System
RA-CMC/ Manufacturing
System
RIM System
CMC/Supply chain/Labeling
System
PV System
eDMS
RIM System
RA-CMC/ Manufacturing
System
RA-CMC/ Manufacturing
System
ISO IDMPISO IDMP
Excel
CMC/Supply chain/Labeling
System
PV System
eDMS RIM System I
RIM System
RA-CMC/ Manufacturing
System
ISO IDMPISO IDMP
RIM System II
RIM System III
File Share
PV System II
RA-CMC/ Manufacturing
System
Multiple data containers
Enterprise Architecture Framework IDMP
IDMP BUS/Datawarehouse
Source: Cabeus Inc.
Business processes Related/ in scope? Process output? Timing and dependencies?
Source data Identification source data in scope Structured/ Unstructured? Quality Ownership Dependencies
Data consolidation and transformation
Format Definitions and mappings Quality
IDMP output Format Consistency and transparency QA
Business processes to IDMP
Data consolidation
and transformation
Source data
Business Process
IDMP output
Harmonize process output (definitions)
Synchronize and tune timeliness
Revised scope required?
Changed output requirements (e.g. from optional to mandatory)
Changed data quality requirements
Process output format requirements
Considerations for processes impacted
MRP numbers in RIM systemNL/H/NL/H/545/E/001NL/545/001/E/01 NL/H/545/01NL/H/545/E/01
Differences due to;1st wave, 2nd wave and other suffixes Inconsistencies in syntax used (spaces and zero’s) Inconsistent use across MAH’s and Agency communications
“What is considered as THE MRP/DCP number by the Company?”
Current Procedural document “Regulatory Affairs Officer stores MRP/DCP number in RIM system”
Example on process output requirements
“Newly approved labeling has been uploaded in eDMS, but…
document status is still “for approval”information in RIM system is not updated (yet)Data fields in RIM system are updated, link to labeling document still point to previous version
Withdrawals/ non-renewalsSmPC still in eDMS as “current approved”
Multiple “current” versions of the same
SmPC
Process timeliness: example on XEVMPD
Data consolidation challenges
Formulation identifierCountryMA numberPackagingBatch identifiersGTIN code
Formulation identifierCountryMA numberFormulationIndicationsPatient populationsSubstance
Match information by unique key
Unique Key
Formulation identifier, Country, MA numberFormulationIndicationsPatient populationsSubstancePackagingBatch identifiersGTINLabeling information
IDMP
Formulation identifierCountryMA numberPackagingBatch identifiersGTINLabeling information
Formulation identifierCountryMA numberFormulationIndicationsPatient populationsSubstance
Data consolidation challenges
MA numbers
PL123780769/01RVG 1234A.I.C. No. 2340661234
MA numbers
PL123780769/01RVG123423406(8723)
Various sources used for “same” structured data
SmPC / PIL
Reg. certificate
Legacy RIM
Local Affiliate
Master Data Management!
RIM system “NL number”
XEVMPD messaging system “Production code”
Harmonized authoritative sources
“What is considered as THE authorization number by the Company AND Agencies?”
AIFA:“Extension in MA number should no longer be used, but SmPCs will be updated gradually”
RIM: 03688719
SmPC: 03688719/G
Potential issues:Gradual SmPC updates may take yearsSubmission XEVMPD/ IDMP rejected or “corrected” by Agency
Data consolidation challenges
RIM vs. Agency reference source for validation
Primary internal source vs. Agency reference source
Reg. certificate
SmPC / PIL
XEVPRM XML
This MA number is
not present in SmPC?
Agency
RIM
Harmonisation within Agency
XEVMPD Rapporteur Administration
See Registration Certificate
See Approval
letterSee
Section 8 of SmPC
Where to find the
official MA number for
IDMP?
MAH
But can also be found in…. Requesting information provided before, in different formats..
Authoritative sources for IDMP?
Where to find the
official MA number?
MAH
IF(country = “France”; THEN)
(IF country = “Italy”; THEN)
IF(country = “US”; THEN)
IF(country = “EU”; THEN)
IF(country = “NL”; THEN)
Consider impact on populating of data container(s)…
IDMP BUS/Datawarehouse
Reg. certificate Commision decision SmPC
Local definitions of what “MA Number” represents
Sodium chloride 0,9% Solution for infusion/ injection
MA number – L1
MA numbers – L2
MA numbers – L3
MA numbers – L4
Renewals!
Recently changed definition
Consider impact on rules for data inheritance across data containers/ IDMP data warehouse…
IDMP BUS/Datawarehouse
MA: 1234 MA: 1234-1 MA: 1234-2
Additional layers of complexity working with multiple internal data containers
RIM System I
RIM System II
RIM System III
Scope may vary: - Global or limited geographical coverage?- All products or subset?- Before/after 2010?
Quality may vary:- Completion and accuracy- Timeliness- QA
Format may vary:- Structured/ unstructured data- System specific organisation- System limitations - QA
365 - 24/7
Time challenge: IDMP baseline vs. ongoing maintenance
Not all MA numbers are entered correctly, e.g. as a range
OGYI-T-21735/01
OGYI-T-21735/02 OGYI-T-21735/01-03
OGYI-T-21735/03
Market presentations not created/ completed
Procedure types not correct, e.g. first national MRP/DCP
Duplicate product entries with different status (e.g. Current/Cancelled)
MA number(s) assigned at incorrect level/ Multiple levels for same record
Examples on internal quality challenges
MPID 1
MPID 2
MPID 3
Source: Registration CertificateMA no. Level 3
Source: SmPCMA no. Level 4
Source: SmPCMA no. Level 1
IDMP = Harmonised OUTPUT definitions
“Tunnel vision"
Ability to cross-check and validate information?
Trust our data Quality; we have a
SOP in place
“Helicopter view”
CompletionInconsistencies
Timeliness
Reference sources
This is supposed to look the
same?
Information provided by Local affiliate
Data entry/ transformation and coding by Central data management group, as applicable
Data accessible directly via “read-only”
Consider “Hybrid” model to distinguish between “critical” and “non-critical” data fields
Reccomendations for data management within single container
Centralised Data Management Group
Aff-1
Aff-2
Aff-3
Information provided and entered by Local affiliate
Data entry/ transformation and coding validated by Central data management group, as applicable
Reccomendations for data management within single container (II)
Aff-1
Aff-2
Aff-3
Draft Approved
Centralised Data Management Group
Master Data Management!
Definition of ownership and primary/ secondary data containers
Define authoritative data sources
Ensure harmonised definitions What you see is what you get?
Dependencies, change control and governance
Validation requirements
Future development roadmap
Recommendations for data management across containers
IDMP/RIM: Friend or Foe?
• Driver for MDM• Harmonisation
systems/processes• Harmonisation product
information• Rely on data quality• Drives data cleansing• Increased transparency
• Conflicting authoritative sources?
• Complex business rules for data input
• Complex business rules for data transformation
• Potentially complex system architecture
IDMP: Project or Programme?
Driver for Master Data ManagementMDM as a processMDM as data; logical data model
Harmonization of systems and processesWithin same business unit (centralised and decentralised)Across disciplines
Harmonization of product informationAcross productsAcross countries
IDMP: Internal benefits
Rely on data qualityCross-checks across various sources and data containersCleansingQA
Increased transparencyTrack changesAvailability and useability of information
Optimize reuse of data
Business ethics
IDMP: Internal benefits (II)
Approximately 70% of IDMP data is captured in unstructured data containers
30% of IDMP data is captured in a structured data container
Timeliness? Completion? Accuracy? Format? QA?
Example on XEVMPD: the “monster” named “Data Quality Control methodology for data submitted under Article 57(2) of Regulation (EC) No.726/2004”…
Structured vs. unstructured data containers
EMA started to introduce changes early January this yearStill ongoing?Details?
Example on XEVMPD data control challenges
MAH
EMA QC
EMA QC
Out-of-Sync!
No information on what is changed?
Blocks ongoing
maintenance
submissions
Conflicting timelines (labelling &
CCDS updates > 30 days)
Deviations across national SPC implementations
EMA; “You do not have to do anything as these updates are considered to be correct”
Medicinal product name
All strenght parts are capitalized requirement?
Company name part “corrections”Changing into local distributor namesIntroducing inconsistencies by changing name entered by MAH:
− Introducing dots “.” and spaces− Introducing reference to legal status
“Corrections” in breakdown of Medicinal Product name
IDMP goes beyond “Do we have this information available?” only..
The IDMP model (output) may seem complex organizing input is a lot more challenging..
Harmonization of “output” makes life better
Harmonization of “input” makes life easier (and therefore likely even better)
These type of challenges are not IDMP specific, however IDMP drives MAHs and Agencies to address them
Conclusions
Controlled Vocabulary Maintenance and Ownership
EDQM Standard Terminology
IDMP Coded Concepts
EDQM Standard Terms vs. ISO 11239
Solid
Tablet
Prolonged
No transformation
Swallowing
Oral
Global Substance Registration System (GSRS)
Open source substances software to be implemented by FDA
European Medicines Agency to become the maintenance organisation
Aimed at universal substance definitions, compliant with ISO 11238 and ISO DTS 19844
No automatic acceptance of submission information and consistent change control
Arbitrary process for disagreements
GiNAS/GSRS
Identifier used for ISO 11616 Pharmaceutical products
ID is generated using algorithm same input should always result in same ID output
Consistent with ISO IDMP standard and HL7 Common Product Model (CPM)
Algorithm is made available to all members of IDEX (IDMP External Group) for alpha and beta testing
Will be generated using Open technology
PhPID