leveraging oracle idmp enterprise foundation suite for regulatory compliance
TRANSCRIPT
Leveraging Oracle IDMP Enterprise Foundation Suite for Regulatory ComplianceJanuary 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 ProfileFounded in 1997
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Multiple vendor/industry technology and growth awards
Mark ThackstoneSenior Business ConsultantPerficient
Michael Braun-BoghosDirector 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
EVMPDxEVMPD
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 StandardsISO 11615
Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information
ISO 11240Health informatics — Identification of medicinal products — Data elements and structures for the unique identification
and exchange of units of measurement
ISO 11238Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated information on substances
ISO 11616Health informatics — Identification of medicinal products — Data elements and structures for the unique identification
and exchange of regulated pharmaceutical product information
ISO 11239Health informatics -- Identification of medicinal products -- Data elements and structures for the unique identification 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 11239dose forms,
units of presentation, routes of administration
packaging
ISO 11240units of measurement
ISO 11616regulated pharmaceutical product information
ISO 11615regulated medicinal product
information
ISO 11238substances
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IDMPMPID
Version
Medical Product Name
Marketing Authorisation
Marketing Authorisation
Procedure
Manufactoring Authorisation
Holder :Organisation
Holder :Organisation
Regulator : Organisation
Authorisation Authority : OrganisationPCID 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
StrengthsStrengths
Strengths
Reference Strength
Pharmaceutical Product Ingredient Specified Substances
Substances
Substances
StrengthsStrengths
Strengths
Reference Strength
Route of Administration
Indications
PhPID
SPOR
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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
IDM
P Sy
stem
New MAH
.xml message
EMANew
MAH
ACK
Temp MAH Code
EV ORG = MAH Code
EV Code
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SPOR Implementation (Future Process)Ph
arm
a Co
mpa
ny
IDM
P Sy
stem
New MAH
.xml message
EMAOMS
New MAH
EV Code
EV Code
EmailNew MAH
detailsEmail
EV Code
EV Code
IDMP Submission
.xml message
The Pathway to Compliance
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The “Process”
DBsDBs
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 designGap Analysis
Data Gathering
Technical solution build and validation
IDMP delivery Maintenance
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Project Plan (Gap Analysis)
Project Plan/ Solution design
Gap Analysis
Data Gatheri
ng
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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Project Plan/ Solution design
Gap Analysis
Data Gatheri
ng
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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Project Plan/ Solution design
Gap Analysis
Data Gatheri
ng
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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Project Plan/ Solution design
Gap Analysis
Data Gatheri
ng
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-keyedRequesting SPOR and adding them to the IDMP dictionary
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Project Plan/ Solution design
Gap Analysis
Data Gatheri
ng
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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Project Plan/ Solution design
Gap Analysis
Data Gatheri
ng
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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Project Plan/ Solution design
Gap Analysis
Data Gatheri
ng
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.
Project M
anagement
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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
Mark ThackstoneSenior Business ConsultantPerficient
Michael Braun-BoghosDirector of Safety Analytics, Product Strategy, Oracle Health Sciences
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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
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Oracle IDMP Enterprise Foundation Suite
PLM
TMS Argus
1. Go Beyond DataBring 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 IDMPAfter 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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