idmp compliance as a competitive advantage

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IDMP Compliance as a Competitive Advantage: The requirement to be proactive The Identification of Medicinal Products (IDMP) standards were developed in response to a worldwide demand for internationally harmonised specifications for medicinal products. The EU is the first to implement these standards, with compliance being set for 1 July 2016 Improve Pharmacovigilance Reduce Counterfeits 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 Excipient Active Ingredient SUBMISSIONS MEDICAL AUTHORISATIONS RESEARCH Timeline Build Competitive Advantage Expand data model to IDMP Attributes MDM approach piloted with XEVMPD 2014 2015 1 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 2012 1 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 fines of up to 5% of profit 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

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IDMP Compliance as a Competitive Advantage: Don’t just comply, manage your data!

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Page 1: IDMP Compliance as a Competitive Advantage

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