This document discusses challenges with inconsistent drug product data across different databases, regions, and disciplines. It notes inconsistencies in substance naming, active ingredients listed as excipients, and differences in listed excipients between countries for the same product. Maintaining consistent data in the XEVMPD format is challenging due to issues like using controlled vocabularies versus SmPC data and different MA numbers used across countries. Lessons learned include that inconsistencies across systems and SmPCs become visible when consolidating data, and defining consistent metadata elements and values across disciplines is important to achieve consistent records.

1. Practical XEVMPD Experience; Once
upon a time there was a perfectly clean
database!
Michiel Stam – Manager Regulatory Operations
Qdossier B.V.

2. 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

3. Data consistency

4. 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

5. Data consistency
SUB12639MIG CITRIC ACID
SUB12482MIG CITRIC ACID
MONOHYDRATE

6. 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”

7. Patient benefit/risk ratio
20121025 Pharmacovigilance, XEVMPD and eCTD
Marketing License through CTD
ICSRs
by E2B
PhVg
System
Master
File by
GVP
ICSRs
Manu-
facturing
License
through
GMP
WW
MA
status
RMP
Interface

8. SmPC
Country I
Across regions
Product
A
SmPC
Country II
Across products
Language
EN
Language
National Across languages
Product
B
TranslationsAcross languages
Database
local
Database
HQ
Storage
location
Product information versions

9. 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

10. 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

11. 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

12. Thank you!
Questions?
www.qdossier.com