idmp compliance as a competitive advantage
DESCRIPTION
IDMP Compliance as a Competitive Advantage: Don’t just comply, manage your data!TRANSCRIPT
IDMP Compliance as a Competitive Advantage:The requirement to be proactiveThe Identi�cation of Medicinal Products (IDMP) standards were developed in response to a worldwide demand for internationally harmonised speci�cations for medicinal products. The EU is the �rst to implement these standards, with compliance being set for 1 July 2016
ImprovePharmacovigilance
ReduceCounterfeits
Ensure patient safety
Challenges
No single product reference
No view of relationships
No single view of product
Master Data Management (MDM) enables continuous consolidation of your data, providing a single view of products and relationships across your entire organisation.
An MDM approach to compliance provides a facility to create & manage a single, trusted view of your products for unlimited use both externally and internally.Product
Market
ExcipientActive
Ingredient SUBMISSIONS
MEDICAL
AUTHORISATIONS
RESEARCH
Timeline
Build Competitive Advantage
Expand datamodel to IDMP
Attributes
MDM approach piloted with XEVMPD
2014 20151 July 2016:
IDMP Compliance
2016
Advantages
Faster time to market with consolidated product view
Reduce working capital through better inventory management
Protect product margins by supporting Health Economics and Outcomes analysis
Build patient trust by ensuring patient services have complete data set to hand
Improve decisions through provision of trusted product data
Be Proactive
Goal
XEVMPD Compliance
20121 July 2016:
IDMP Compliance
2016
5%
MAH’s to manage data quality
2014
In 2014 Pharma companies are getting data
quality warnings on current
regulation, where the scope is far
smaller than IDMP
Challenge: Generally data quality is poor
Guidance Issued
2015
Challenge:Enough time for
compliance?
Challenge: Non-compliance
�nes of up to 5% of pro�t
Clinical (3rd party)
IDMP
Clinical
Formulation Marketing Submissions
Manufacturing
Product
A standard view of all medicines marketed within Europe.
IDMP Compliance as a Competitive Advantage:Don’t just comply, manage your data!
This standard view does not exist internally within the pharma company.
Timeline
“It is clear from this that the applicability of IDMP will be wider than that of XEVMPD and so companies should begin to prepare for IDMP as soon as possible.1 ”
“Companies that successfully use data are already outperforming their peers by as much as 20%.” (EY, 2014)
1 http://marrconsultancy.com/wp-content/uploads/2014/05/TOPRA-June-2014-XEVMPD-article.pdf