IDMP and RIM: friend or foe?

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

[email protected]@ectdconsultancy.com

Thank you! Questions?

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