MDM Approach for EVMPD & IDMP Compliance

Transcription

1 MDM Approach for EVMPD & IDMP Compliance Monica McDonnell November 13 th, 2014

2 Agenda Why a MDM Approach for IDMP Compliance? Benefits of a MDM Approach to IDMP

3 The History Behind IDMP EVMPD has required the submission of data regarding human medicinal products in the European Union since July 2012 In general the data quality is deemed too poor for the intended purposes Requirements from December 2014 for MAH s to take responsibility 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

4 Why does EMA require IDMP? There is no unified view of medicines in Europe as a whole due to approach of different product numbers for different strengths, packages and countries Root cause: this lack of unified view exists within pharma companies.

5 The Compliance Challenge How to Synthesize, Govern and Submit Data Across Silos? R&D ion Sales & Marketing (al) Compliance 1 No Single View 2 No View of Relationships 3 No View of Interactions? Data Governance Exipient Submiss... Compound Compound Authoris.. Exipient Authoris.. Submiss.. Cloud & CROs Application Legacy R&D Third Party Data 5

6 What is Master Data Management? MDM is about listening and linking and coordinating the unique identifying elements of things (including compounds, products, authorisation holders, suppliers and customers) in various systems MDM is more than de-duping its continuous consolidation Think 1. Listening 2. Linking 3. Governing 4. Sharing 6

7 Is IDMP different to previous regulations? R&D ion Sales & Marketing EMA Compliance FDA draft 2014 PMDA??? A global lexicon for product data is being developed. EMA is an early mover, but other countries are expected to adopt the IDMP ISO standard too? Data Governance Exipient Submiss... Compound Compound Authoris.. Exipient Authoris.. Submiss.. Cloud & CROs Application Legacy R&D Third Party Data Controlled Vocabulary 7

8 Map Once, Deploy Anywhere R&D ion Sales & Marketing EMA FDA draft 2014 PMDA??? Compliance How many times do you really want to source, populate, clean and manage this data?? Data Governance Exipient Submiss... Compound Compound Authoris.. Exipient Authoris.. Submiss.. Cloud & CROs Application Legacy R&D Third Party Data 8

9 EMA IDMP Scope for 2016 Marketing Submissions & Authorisations Labelling Clinical Who in your organisation would benefit from complete, accessible and integrated medicinal product data? Medicinal Pharmaceutical Manufacturing Devices

10 MDM as a Core Regulatory Enabler Applications Regulatory Legacy Master Data Management Deliver Timely, Trusted, Relevant Master Data Legacy RIMs Model Cleanse R&D 3 rd Party A trusted repository for management of medicinal product data: Accurate, Consistent, Complete Discover Govern Recognise CROs Analytical Relate Resolve Business Intelligence 10

11 Screen Shots EVMPD data model Graphical views are available by any object; example here of the relationships from a medicinal product to pharmaceutical product, submissions & attachments Tabular View of Details History View illustrates any changes to product and related objects 11

12 Agenda Why a MDM Approach for IDMP Compliance? Benefits of a MDM Approach to IDMP

13 A MDM approach will leverage your IDMP compliance budget to deliver measurable business value across multiple internal functional areas. 13

14 MDM has a High Correlation with Spend reduction Inventory reduction Improved Customer/Patient Service And adds significant value to implementing Quality by Design/Continuous Process Verification Traceability solutions Health Economics & Outcomes Analysis Banned substances importation monitoring 14

15 Alternate Solutions for Compliance Data Warehouse Master Data is not static, it must be managed, but no MDM Specific UI DW requires master data to be modelled Changes required to support IDMP/EVMPD may have far-reaching consequences MDM tool will enhance data quality within existing Data Warehouses Regulatory Tool Focus on the submission process Not designed for managing dynamic nature of master data across many source systems 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 High Broad Investments in Process Change and System Enhancements to maximize Clinical and Financial Benefits Business Process Remediation Level of IDMP Benefit Minimal Bare Minimum for Compliance Low Minimal Dramatic Level of IDMP Investment 16

17 SELECTING THE RIGHT OPTIONS Level of IDMP Benefit High Optimize for Analytics Optimize for Financial Benefit Optimize for Clinical Benefit Business Process Remediation Minimal Low Minimal Dramatic Level of IDMP Investment 17

18 Benefits of MDM Approach for Compliance Specifically designed for gathering and managing the dynamic nature of master 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

19 MDM in Action Core Enabler of Quintiles Infosario Between 2004 and 2011, Quintiles helped develop or commercialize 72% of all NME/BLA products*. BUT, the business continued to be hampered by: *Quintiles report as of March 31 st,

20 Business case for Multidomain MDM Continuous secure access to up-to-date information for oversight and accountability 20

21 Informatica MDM Informatica MDM empowers companies to improve operations with business-user access to single, trusted view of businesscritical data about customers, products, channel partners and employees and the view of relationships among them along with all customer interactions across the enterprise. Market Impact 700+ customers in 35+ industries across 20+ countries 100+ business solutions across customers 50+% of Fortune 500 and Global 500 customers Deployment Impact The Forrester Wave : Master Data Management (MDM) Solutions, Q data domains across customers Rapid customer deployments (average 3 6 months) On-premise, cloud, hybrid, hosted deployment modes Informatica s Universal MDM story has been successful and it has been garnering an increasing number of multidomain customers across different industries. MDM Landscape, Information Difference, Q2 2103

22 Questions?

23 Part of Informatica s Intelligent Data Platform Data-Fueled Applications The Intelligent Data Platform Data Intelligence Metadata Meets Machine Learning New Live Data Map Inference Engine MDM is key to data management of the future: Right Data Right Way Right Away Role-Based Data Management Tools Data Infrastructure Data Feed Data Integration Vibe Virtual Data Machine Data Quality and Mastering Data Security Industry- Leading Infrastructure Services Data Persistence