Practical XEVMPD Experience; Once upon a time there was a perfectly clean database!

Michiel Stam – Manager Regulatory OperationsQdossier B.V.

Quality source data

• Inconsistent data across:– Products– Regions– Disciplines (incl. local and central RA)

• Incorrect, incomplete and inconsistent data• Leading to discussions about:– Inconsistency between databases– Semantics– Formats and values

Data consistency

XEVMPD format

• SmPC data versus controlled vocabulary• MedDRA vs SmPC indication• Concentrations• Use in Children• Inconsistent use of MA number across

Member States• Legacy EVMPD data• Moving targets for EV codes

Data consistency

SUB12639MIG CITRIC ACID

SUB12482MIG CITRIC ACID MONOHYDRATE

Consistency in drug substance

• Challenges and inconsistencies across substance naming:– Substance listed as Excipient in country A and as Active

in country B– Differences across ingredients for what should be the

same product (e.g. 4 excipients listed in country A and 5 excipients

listed in country B) – “Glucose, anhydrous 80 g/1000ml” versus “Glucose 80

g/1000ml”– “Arginine” versus “Arginine glutemate” versus “Arginine

monoglutemate”

Pharmacovigilance, XEVMPD and eCTD

Patient benefit/risk ratio

20121025 Marketing License through CTD

PSUR

ICSRsby E2B

Clinical

studiesNo link yet between ICSRs and

quality of the product

RMP

Literature

XEVMPD / IDMP

Educa-tional program

PhVgSystemMasterFile byGVP

ICSRs

Summary of PSMF

Quality docu-ments

Product

infor-

mation

Manu-facturing License through

GMP

WW MA

status

RMP Interface

Cover letter

Appli-cation form

Enve-lope Portal

SmPC Country I

Across regions

Product A

SmPC Country II

Across products

Language EN

Language National

Across languages

Product B

Translations

Across languages

Database local

Database HQ

Storage location

Product information versions

Facilitating increased transparency

• Process establishment across disciplines• Standardised terminology (generic)• Unique data identifiers• Model relationships between data IDs• Ownership and master data management• Minimize duplication of data across systems• Quality by Design• Dare to rely on your colleague's data

Tool

• XEVMPD as part of registration tracking database• Support product dictionaries and company specific

data model• Standardised terminology (generic)• Unique data identifiers• Model relationships between data IDs• Ownership and master data management• Minimize duplication of data across systems• Quality by Design• Dare to rely on your colleague's data

Lessons learned• Inconsistencies across products and countries become

visible• Inconsistencies across systems and SmPCs become visible• Gaps and inconsistencies due to decentralised approach

(shared responsibilities) • Same contents, different format leads to multiple records • Definition of metadata elements and values must be

implemented within all disciples to achieve consistent records (e.g. substance list versus SmPC)

• Always consider what is the primary data source

Thank you!

Questions?www.qdossier.com