Leveraging Oracle IDMP Enterprise Foundation Suite for Regulatory Compliance

Leveraging Oracle IDMP Enterprise
Foundation Suite for Regulatory
Compliance
January 2017

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About Perficient
Perficient is the leading digital transformation
consulting firm serving Global 2000 and enterprise
customers throughout North America.
With unparalleled information technology, management consulting,
and creative capabilities, Perficient and its Perficient Digital agency
deliver vision, execution, and value with outstanding digital
experience, business optimization, and industry solutions.

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Perficient Profile
Founded in 1997
Public, NASDAQ: PRFT
2015 revenue $473.6 million
Major market locations:
Allentown, Atlanta, Ann Arbor, Boston, Charlotte,
Chattanooga, Chicago, Cincinnati, Columbus, Dallas,
Denver, Detroit, Fairfax, Houston, Indianapolis, Lafayette,
Milwaukee, Minneapolis, New York City, Northern California,
Oxford (UK), Southern California, St. Louis, Toronto
Global delivery centers in China and India
3,000+ colleagues
Dedicated solution practices
~95% repeat business rate
Alliance partnerships with major technology vendors
Multiple vendor/industry technology and growth awards

Mark Thackstone
Senior Business Consultant
Perficient
Michael Braun-Boghos
Director of Safety Analytics, Product
Strategy, Oracle Health Sciences

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• A quick introduction to IDMP/Article 57
• SPOR
• IDMP project planning
• Summary
• Oracle IDMP Enterprise Foundation Suite
• Q&A
Agenda

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• Since the 80’s, safety databases were growing
• MCA/MHRA – Sentinel
• FDA AERS
• EudraVigilance
• No common standard; meta analysis handicapped by the lack of common standards
• ISO IDMP
IDMP History

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• IDMP falls within a series of initiatives under the
EU Telemetrics Strategy
• Other initiatives include management of
clinical trials, monitoring of
pharmacovigilance literature, provision
of a single portal for drug authorization
applications
• IDMP is unique in several ways:
• It is multi-disciplinary
• It underpins several of the other
applications
• It is part of a joint initiative
between the members of the
International Conference on
Harmonisation (ICH)
In Europe

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• Regulation (EC) No. 726/2004/EU, Article 57 & Regulation (EU) No520/2012 (articles 25 and 26)
• Mandates that Marketing Authorization Holders (MAH) are required to submit information electronically
on all medical products for Human use
• Since 02-Jul-2012 according to a standard described by the EMA – EVMPD
• Since 16-Jun-2014, MAHs need to update to a new standard – xEVMPD (eXtended EVMPD)
• As of July 2016, MAHs need to move to the next standard
• This standard is EVMPD-compliant with the relevant ISO standards
• DON’T PANIC – it is understood that this legal requirement is unachievable and an incremental plan has been
put in place reach the objective
In Europe
EVMPD
xEVMPD
IDMP

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• EVMPD on Steroids!
• Application of ISO standards to Article 57 product data collection
• This standard was developed in response to a worldwide demand for internationally
harmonized specifications for medicinal products. It is one of a group of five standards,
which together provide the basis for the unique identification of medicinal products.
• It provides data elements and structures for unique identification and exchange
What is IDMP?

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ISO Standards
ISO 11615
Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange
of regulated medicinal product information
ISO 11240
Health informatics — Identification of medicinal products —
Data elements and structures for the unique identification
and exchange of units of measurement
ISO 11238
and exchange of regulated information on substances
ISO 11616
and exchange of regulated pharmaceutical product
information
ISO 11239
Health informatics -- Identification of medicinal products --
and exchange of regulated information on pharmaceutical
dose forms, units of presentation, routes of
administration and packaging

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ISO Standards
Product Package
ISO 11239
dose forms,
units of presentation,
routes of administration
packaging
ISO 11240
units of measurement
ISO 11616
regulated pharmaceutical product information
ISO 11615
regulated medicinal product
information
ISO 11238
substances

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IDMPMPID
Version
Medical Product Name
Marketing
Authorisation
Marketing
Authorisation
Procedure
Manufactoring
Authorisation
Holder :Organisation
Holder :Organisation
Regulator : Organisation
Authorisation Authority :
Organisation
PCID Outer Packaging Physical Characteristics
Package Item
Package Item Package Item Part Package Item Part
Package Item Part
Substances
Manufactured Item Ingredient Specified Substances
Substances
Substances
Strengths
Strengths
Strengths
Reference Strength
Pharmaceutical
Product Ingredient Specified Substances
Substances
Substances
Strengths
Strengths
Strengths
Reference Strength
Route of Administration
Indications
PhPID

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SPOR
• Transition plan from Article 57/XEVMPD data
submission to SPOR

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• One thing that is apparent is a large amount of the data is shared or common
• Some of these data types are well defined, controlled, and managed in dictionaries and code
lists
• MedDRA Country and language lists (ISO 3166 and ISO 639)
• International units
• ATC
• Where these exist, IDMP adopts them
• However, what to do about those that are common data points, but are not defined?
• This was one of the lessons learned from previous iterations of the Art. 57 database,
and the EMA have accepted responsibility for organizing and harmonizing codes for
data points such as substances
SPOR and Master Data Management

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• Substance - describing the ingredients of a
medicine;
• Product - describing the marketing and
medicinal information relating to a product;
• Organisation - providing the contact
details of organisations and individuals
responsible for various aspects of a
medicine;
• Referential, providing controlled
vocabularies (e.g., dosage, pharmaceutical
forms, country codes, package codes,
weight codes) for a medicine, which are
explicitly defined for use in Europe.
SPOR and Master Data Management
Referencials
Organisation
Products
Substances

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SPOR Implementation
• On the 1-Dec-2016 the EMA published a transition
plan from Article 57/XEVMPD data submission to
SPOR

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SPOR Implementation (Current Process)
Pharma Company
IDMPSystem
New
MAH
.xml message
EMA
New
MAH
ACK
Temp MAH Code
EV ORG = MAH
Code
EV Code

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SPOR Implementation (Future Process)PharmaCompany
IDMPSystem
New
MAH
.xml message
EMA
OMS
New
MAH
EV Code
EV Code
Email
New MAH
details
Email
EV Code
EV Code
IDMP
Submission
.xml message

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The “Process”
DBs
DBs
DBs
DBs
DBs
Staging
Area
Data
Mart
Data
Mart
Data
Vault
Other
Company
Purposes
Paper
Sources
Data
transformed
into IDMP
IDMP

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Project Plan
Project Plan/ Solution
design
Gap Analysis
Data Gathering
Technical solution build
and validation
IDMP delivery Maintenance

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Project Plan (Gap Analysis)
design
Gap Analysis
Data
Gathering
Technical
solution
build and
validation
IDMP delivery
Maintenance
Technical
• Inventory of systems/DBs
• Data bases
• IDMP System?
• Project Management system
Data
• Where is it
• What format is it
• Paper
• Electronic
• Structured Electronic
Resource
• Budget
• Time
• FTE
• Departments/ Teams

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design
Gap Analysis
Data
Gathering
Technical
solution
build and
validation
IDMP delivery
Maintenance
Project Plan (Project Plan/Solution Design)
Who is going to come up with the solution?
• What expertise do you have in house?
• Do you need consultant support?
• What strategy are you going to adopt
• Which direction does your Gap Analysis point you?

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design
Gap Analysis
Data
Gathering
Technical
solution
build and
validation
IDMP delivery
Maintenance
Project Plan (Technical Solution, Build, Validation)
Installation, Validation
• Leveraging and linking existing systems with new systems

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design
Gap Analysis
Data
Gathering
Technical
solution
build and
validation
IDMP delivery
Maintenance
Project Plan (Data Gathering)
Getting the data in one place
• Data already in IDMP format
• Data that can be mapped or transformed to the IDMP format
• Data that needs to be re-keyed
Requesting SPOR and adding them to the IDMP dictionary

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design
Gap Analysis
Data
Gathering
Technical
solution
build and
validation
IDMP delivery
Maintenance
Project Plan (IDMP Delivery)
Submitting the xml and monitoring the .acks for compliance.

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design
Gap Analysis
Data
Gathering
Technical
solution
build and
validation
IDMP delivery
Maintenance
Project Plan (Maintenance)
Post launch
• Updating submitted IDMP records as the product moves through its life cycle
• Submitting new products
• Data clean up activities as directed by the EMA
Who is going to do this? Regulatory? Safety? An IDMP team?

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design
Gap Analysis
Data
Gathering
Technical
solution
build and
validation
IDMP delivery
Maintenance
Project Plan (Project Management)
Maintaining control over this project is challenging because it involves
multiple streams of activity so metrics and oversight should be built into the
project plan.ProjectManagement

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• Have you completed a Gap Analysis?
• Our consultants can assist with completing this activity expeditiously
• Do you have data that needs to be transformed to be useful for IDMP?
• We have the technology and the expertise to maximize the amount of usable data
• Do you have a technological solution for creating and submitting your IDMP messages?
• We can assist you with the selection, installation, and validation of your solution
• Do you have oversight of your compliance with IDMP or your IDMP Project Plan?
• Take a look at the Oracle IDMP offering for an end to end solution
Status Review

32Copyright © 2016, Oracle and/or its affiliates. All rights reserved.
 US $38.2 billion in revenue in FY2015
 US $4.9 billion in R&D
 420,000 customers in 145 countries
 130,000 employees worldwide
including:
 37,000 developers and engineers
 18,000 support personnel
 17,000 consulting experts
 25,000 partners
 More than 2.6 million students
supported annually
►The Scale of Oracle
 #1 clinical development software (2015 IDC report) and
#1 commercial safety database (2014 ISR report)
 Powered 37 of 45 novel FDA-approved drugs in 2015
 Regulators choose Oracle safety solutions including
FDA, MHRA, Denmark, Saudi Arabia, and South Korea
 #1 in site satisfaction worldwide (2015 ISR report)
 Thousands of employees worldwide with life sciences
and healthcare domain expertise, including dedicated
software engineers and services personnel
 Dedicated offices across North America, EMEA, and
Asia-Pacific
 Global support in multiple languages
►A Focus on Life Sciences and Healthcare
Oracle’s commitment to industry R&D fuels domain-specific technology innovation

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Oracle placed first among all life science software
vendors* in every assessment IDC Health Insights
has published from its initial report for 2008 to its
latest report for 2015
Source: IDC Health Insights reports US40503316, HI254753, HI247889, HI240273,
HI234226, HI225921, and HI218060
Oracle is the #1 Life Science Software Vendor
* Ranked by license revenue and share

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Oracle IDMP Enterprise Foundation Suite
PLM
TMS Argus
1. Go Beyond Data
Bring together not just the data, but the business
processes from currently siloed departments
2. Go Beyond Regulatory Affairs
Look at the bigger picture including coding,
terminology management, and safety compliance
3. Go Beyond IDMP
After ensuring IDMP compliance, use the same
solution to gain additional benefits and address
future needs

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Oracle IDMP Enterprise Foundation Suite
PLM
TMS Argus
• Covers end-to-end IDMP requirements
• Suite components are existing, mature products and
market-leaders in their space
• Multidisciplinary approvals can be implemented to
mirror the new business process
• Multiple data models and terminologies are
supported, not just IDMP
• Commercial off-the-shelf applications rather than
customizations of generic technology products, and
IDMP is a configuration within the applications
• Best positioned to support EMA's planned IDMP
implementation iterations without requiring frequent
product upgrades or rework of customizations

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Oracle Product Lifecycle Management
TMS Argus
• Centrally manages any attributes of any product
throughout its entire lifecycle
• Used by many industries, not just pharma, including
medical device companies for UDI
• Acts as the central hub for IDMP information for all
company products
• Includes MDM capabilities
• Data can be imported automatically or entered
manually
• After creation of the initial IDMP record, changes are
managed in PLM
• Approval workflows can include users from all
departments that own (parts of) the data
• Generation of IDMP messages to regulators
• Support of other data fields beyond IDMP
• Additional functionality such as project management
PLM

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Oracle Thesaurus Management System
Argus
• Centrally manages any dictionaries and versions of
dictionaries such as MedDRA, SNOMED, WHO-
DDE, WHO-ART, COSTART, ICD10, LOINC, MeSH,
UDI, company-specific, etc.
• Combines the company IDMP records from PLM
with the non-company IDMP records from the health
authorities into a global dictionary
• Users in Argus and other applications look up IDs in
TMS in order to code products and medical terms
against IDMP and other dictionaries
• Mappings across dictionaries can be maintained in
TMS to reduce work for coders
• Clinical particulars can be looked up as unstructured
data becomes structured
PLM
TMS

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Oracle Argus
TMS Argus
• Centrally manages adverse events for all drugs,
vaccines, and medical devices from clinical trials
through post-marketing surveillance
• IDMP IDs can be populated for both company and
non-company products
• Generates E2B(R3) messages including IDMP fields
• Tracking of E2B(R3) submissions,
acknowledgements, and compliance metrics
• Keeps the safety department compliant with the
regulations
• Many additional functionalities beyond IDMP and
E2B(R3), including periodic reporting, business
intelligence, case processing workflow, and Japan
operations
PLM

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LifeSciencesInfo@perficient.com
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Leveraging Oracle IDMP Enterprise Foundation Suite for Regulatory Compliance

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Leveraging Oracle IDMP Enterprise Foundation Suite for Regulatory Compliance