MDM Approach for EVMPD &IDMP Compliance

Monica McDonnell

November 13th, 2014

Agenda

• Why a MDM Approach for IDMP Compliance?

• Benefits of a MDM Approach to IDMP

The History Behind IDMP

• EVMPD has required the submission of data regardinghuman medicinal products in the European Union sinceJuly 2012

• In general the data quality is deemed too poor for theintended purposes

• Requirements from December 2014 for MAH’s to takeresponsibility for the quality of this data

• IDMP is to come into force from 1 July 2016

• Based on the IDMP ISO standard

• Requirements for submission are not yet fully defined

• Much broader scope is anticipated

3

Why does EMA require IDMP?

• There is no unified view of medicines in Europe as a whole due toapproach of different product numbers for different strengths, packagesand countries

• Root cause: this lack of unified view exists within pharma companies.

How to Synthesize, Govern and Submit Data Across Silos?

The Compliance Challenge

DataGovernance

?

Sales &Marketing

R&D(Regional)

Compliance

Region

Submiss..

Compound

Product

Product

Authoris..Exipient

RegionSubmiss...

RegionProduct

ExipientProduct

Authoris..Compound

Region

Application LegacyR&D

Third Party DataCloud & CROs

No View of Interactions

3

No View of Relationships

2

No Single View

1

5

Production

What is Master Data Management?

• MDM is about listening and linking and coordinating the uniqueidentifying elements of things (including compounds, products,authorisation holders, suppliers and customers) in various systems

6

• MDM is more than de-duping –its continuous consolidation

• Think…

1. Listening

2. Linking

3. Governing

4. Sharing

7

Is IDMP different to previous regulations?

DataGovernance

?

Compliance

Region

Submiss..

Compound

Product

Product

Authoris..Exipient

RegionSubmiss...

RegionProduct

ExipientProduct

Authoris..Compound

Region

Application LegacyR&D

Cloud & CROs

A global lexicon for product data is beingdeveloped. EMA is an early mover, but othercountries are expected to adopt the IDMPISO standard too

Sales &Marketing

R&D Production

EMA - 2016

FDA – draft 2014

PMDA – ???

Third Party DataControlled Vocabulary

Map Once, Deploy Anywhere

8

DataGovernance

?

Region

Submiss..

Compound

Product

Product

Authoris..Exipient

RegionSubmiss...

RegionProduct

ExipientProduct

Authoris..Compound

Region

Application LegacyR&D

Third Party DataCloud & CROs

How many times do you really want tosource, populate, clean and manage this

data?

Sales &Marketing

R&D Production Compliance

EMA - 2016

FDA – draft 2014

PMDA – ???

EMA IDMP Scope for 2016

Clinical Medicinal Product

PharmaceuticalProduct

Devices

Labelling

Manufacturing

Marketing Submissions& Authorisations

Who in your organisation would benefit fromcomplete, accessible and integrated medicinal

product data?

MDM as a Core Regulatory Enabler

10

Master Data Management

Cleanse

Recognise

ResolveRelate

Govern

Model

Deliver Timely, Trusted, Relevant Master Data

Discover

Legacy

BusinessIntelligence

Analytical

Regulatory

RIMs

Legacy

Applications

R&D

3rd Party

CROs

A trusted repository formanagement ofmedicinal product data:Accurate, Consistent,Complete

Screen Shots EVMPD data model

11

Tabular View of ProductDetailsGraphical views are available

by any object; example hereof the relationships from a

medicinal product topharmaceutical product,

submissions & attachments

History View illustratesany changes to product

and related objects

Agenda

• Why a MDM Approach for IDMP Compliance?

• Benefits of a MDM Approach to IDMP

13

A MDM approach will leverage your IDMPcompliance budget to deliver measurablebusiness value across multiple internalfunctional areas.

14

Product MDM has a High Correlation with…

• Spend reduction

• Inventory reduction

• Improved Customer/Patient Service

And adds significant value to implementing…

• Quality by Design/Continuous ProcessVerification

• Traceability solutions

• Health Economics & Outcomes Analysis

• Banned substances importation monitoring

Alternate Solutions for Compliance

Data Warehouse

• Master Data is not static, it must bemanaged, but no MDM Specific UI

• DW requires master data to be modelled• Changes required to support

IDMP/EVMPD may have far-reachingconsequences

• MDM tool will enhance data quality withinexisting Data Warehouses

Regulatory Tool

• Focus on the submission process• Not designed for managing dynamic

nature of master data across many sourcesystems

• Limited use cases• Can work in conjunction with MDM tool for

final submission

Manual Approach (Excel)

• Not scalable• High on-going cost due to hands-on

management requirements• Does not manage change or version

control well• Tends to undermine overall data quality

15

16

SELECTING THE RIGHT OPTIONS

Level of IDMP Investment

Le

ve

lo

fID

MP

Be

ne

fit

Minimal Dramatic

Low

High

Minimal

BusinessProcess

Remediation

Bare Minimum forCompliance

Broad Investments in ProcessChange and System

Enhancements to maximizeClinical and Financial Benefits

17

SELECTING THE RIGHT OPTIONS

Minimal Dramatic

Low

High

Minimal

BusinessProcessRemediation

Optimizefor

Analytics

Optimizefor Clinical

Benefit

Optimize forFinancialBenefit

Level of IDMP Investment

Le

ve

lo

fID

MP

Be

ne

fit

Benefits of MDM Approach for Compliance

• Specifically designed for gathering and managing the dynamic nature ofmaster data

• Strength in dealing with multiple source and target systems

• Easily model, capture and maintain the relationships between master data entities

• Enhances functionality of other systems (compliance + others)

• Enable & support improved data governance

• Reduce creation of non-unique master data identifiers

• Ability to identify & aid the resolution of missing data

• Leading to improved corporate data quality

• High re-use potential across the enterprise

• Build a trusted master data foundation

• Enable a single view of products across the corporation

• Basis for fast, agile regulatory compliance in the future

• Enhance internal and external communication

• Business efficiency & streamlining

18

MDM in Action – Core Enabler of QuintilesInfosario™

19

Between 2004 and 2011, Quintiles helped develop orcommercialize 72% of all NME/BLA products*.

BUT, the business continued to be hampered by:

*Quintiles report as of March 31st, 2013

Business case for Multidomain MDM

20

Continuous secure access to up-to-date information foroversight and accountability

Informatica MDM

Informatica MDM empowers companies to improve operationswith business-user access to single, trusted view of business-critical data about customers, products, channel partners andemployees – and the 3600 view of relationships among them –along with all customer interactions across the enterprise.

• 700+ customers in 35+ industries across 20+ countries

• 100+ business solutions across customers

• 50+% of Fortune 500 and Global 500 customers

Market Impact

• 100+ data domains across customers

• Rapid customer deployments (average 3 – 6 months)

• On-premise, cloud, hybrid, hosted deployment modes

Deployment Impact

“Informatica’s Universal MDM story has been successfuland it has been garnering an increasing number ofmultidomain customers across different industries.”

The Forrester Wave™: Master DataManagement (MDM) Solutions, Q1 2014

MDM Landscape, Information Difference, Q22103

Questions?

Part of Informatica’s Intelligent Data Platform

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MDM is key todatamanagementof the future:• Right Data• Right Way• Right Away