Leveraging Oracle IDMP Enterprise Foundation Suite for Regulatory Compliance
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IDMP (Identification of Medicinal Products), which will soon be mandated by the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA), will enable stakeholders to obtain a comprehensive view of each individual product (e.g., ingredients, marketing and medicinal information, contacts), based on unique codes. While the journey towards IDMP compliance can be incredibly challenging, industry-specific knowledge and systems play an integral role in meeting the new requirements. In our webinar, we discussed how the Oracle IDMP Enterprise Foundation Suite can help you be ready in time.
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Leveraging Oracle IDMP Enterprise Foundation Suite for Regulatory Compliance
- 1. Leveraging Oracle IDMP Enterprise Foundation Suite for Regulatory Compliance January 2017
- 2. 2 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.
- 3. 3 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
- 4. Mark Thackstone Senior Business Consultant Perficient Michael Braun-Boghos Director of Safety Analytics, Product Strategy, Oracle Health Sciences
- 5. 5 • A quick introduction to IDMP/Article 57 • SPOR • IDMP project planning • Summary • Oracle IDMP Enterprise Foundation Suite • Q&A Agenda
- 6. 6 • 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
- 7. 7 • 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
- 8. 8 • 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
- 9. 9 • 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?
- 10. 10 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 Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated information on substances ISO 11616 Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information ISO 11239 Health 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
- 11. 11 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
- 12. 12 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
- 13. SPOR
- 14. 14 SPOR • Transition plan from Article 57/XEVMPD data submission to SPOR
- 15. 15 • 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
- 16. 16 • 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
- 17. 17 SPOR Implementation • On the 1-Dec-2016 the EMA published a transition plan from Article 57/XEVMPD data submission to SPOR
- 18. 18 SPOR Implementation (Current Process) Pharma Company IDMPSystem New MAH .xml message EMA New MAH ACK Temp MAH Code EV ORG = MAH Code EV Code
- 19. 19 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
- 20. The Pathway to Compliance
- 22. 22 Project Plan Project Plan/ Solution design Gap Analysis Data Gathering Technical solution build and validation IDMP delivery Maintenance
- 23. 23 Project Plan (Gap Analysis) Project Plan/ Solution 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
- 24. 24 Project Plan/ Solution 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?
- 25. 25 Project Plan/ Solution 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
- 26. 26 Project Plan/ Solution 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
- 27. 27 Project Plan/ Solution 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.
- 28. 28 Project Plan/ Solution 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?
- 29. 29 Project Plan/ Solution 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
- 30. 30 • 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
- 31. Mark Thackstone Senior Business Consultant Perficient Michael Braun-Boghos Director of Safety Analytics, Product Strategy, Oracle Health Sciences
- 32. 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
- 33. 33 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
- 34. 34 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
- 35. 35 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
- 36. 36 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
- 37. 37 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
- 38. 38 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
- 39. 39 [email protected] Request a Demo or More Information
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- 42. Thank You