EMA SPOR master data management roadmap EU ISO IDMP Task Force meeting – For information – March 2015 Presented by: Kepa Amutxastegi Business Data and Support Department An agency of the European Union
Roadmap and the overall EMA strategy • Roadmap developed to meet EMA business priorities and provide stakeholder benefits • Initial analysis based on EMA consultation, NCA input and industry Roadm ap position paper 1 approach • High level approach for delivering SPOR MDM services agreed by EMA leadership • Based on principles agreed by the EU Telematics workshop (Feb 2015): Stakeholder -Simplicity, phased approach & show value with each phase engagem ent • EMA Referential and Organisation MDM implementation projects following the strategy and guidance defined by this roadmap • Implementation principles for the roadmap are to be iterative, gradual and incremental to lower risks, deliver services sooner, and help I m plem entation stakeholder engagement 1 EU Task Force meeting - SPOR roadmap - March 2015 1. Principles for the implementation of ISO IDMP standards for EudraVigilance and development of a roadmap, EFPIA, 2014
Benefits of roadmap implementation Holistic MDM as part of EU philosophy MDM services integrated w ith stakeholder business processes Data as an EU asset Strategic Process orchestration Benefits Consolidated data governance Easier im plem entation of new initiatives ( I T agility) Partnership w ith stakeholders I ntegration w ith m ore applications and Tactical Full SPOR MDM im plem entation processes Lim ited initial scope Engage stakeholders I m plem ent full S, P and O MDM services Full m edicinal product life cycle ( Hum an & Vet) Establish stew ardship I m plem ent R MDM service Com pliance w ith legal requirem ents Start m easuring Gain experience progress 2 2 0 1 5 Foundational Efficiency & Com pliance Effectiveness 2 0 2 0 +
Practical applications of MDM services • Pharmacovigilance • ICSR and Art. 57 data submissions • Clinical Trials legislation Short/ Medium • Clinical Trials portal & database • Regulatory submissions term • eAF , Referrals, PSUR repository, eCTD, Gateway, Single submission portal • Falsified Medicines legislation • EudraGMDP support • Future initiatives • ePrescription Long term • Other regulatory submissions • Scientific Advice/ Orphan/ Paediatrics applications, Veterinary products 3 EU Task Force meeting - SPOR roadmap - March 2015
Critical success factors W ell defined & robust governance m odels I nvestm ent Alignm ent of and data, preparation processes & for change system s SPOR MDM im plem entation critical success factors I SO I DMP Data technical enrichm ent specifications for I DMP adopted com pliance Organisation End user aw areness of acceptance of MDM services MDM services 4 EU Task Force meeting - SPOR roadmap - March 2015
MDM services and stakeholder readiness Services Description • Establishment of the processes and technology capability for EMA and relevant stakeholders to participate in the registration Registration and and maintenance of the master data m aintenance of m aster data • Service provided will be based on the agreed operating model within the EU as well as the EMA • Access to data may be provided systematically via system interfaces, or/ and via web user interfaces. Access and exchange of data • Interfaces will need to be ISO IDMP compliant and enable data exchange and integration across systems. • Stakeholders consuming these EMA MDM services will require support in the form of: o Guidance documentation Custom er services o Training o Direct helpdesk support 5 EU Task Force meeting - SPOR roadmap - March 2015
MDM services and stakeholder readiness Area Requirem ent from stakeholders • For reading/ querying data, web services may require consumers to provide security credentials and adapt systems to make use of the new message format (HL7 v3). • Read / query functionality will be exposed through a User Technology Interface (UI) enabling users to query directly, which can also be embedded into existing application UIs. • Security credentials are essential for users to author data/ submit change requests. Functionality will also be exposed through a User Interface. • Early engagement with EMA for change management activities Processes during the development of MDM services is recommended • Service users will need to be aware of new policies, service level agreements, and processes put in place as part of the service provisioning and consumption • EMA will provide a point of contact for communication and People interaction with future service users • EMA advises the appointment of a representative or small user group to liaison for training, communication, and general support throughout the transition 6 EU Task Force meeting - SPOR roadmap - March 2015
A phased approach for the implementation Future state Transitional Current state state Stepw ise, iterative MDM im plem entation projects Data consolidation and integration Change m anagem ent Partnership w ith industry and NCAs 7 EU Task Force meeting - SPOR roadmap - March 2015
Roadmap high level activity plan 8
Change management planning Change Organisational Know ledge Training Preparation Alignm ent Transfer Assess Agency, NCA Align stakeholders Plan, design, Plan, design, and industry w ith goals and execute, and develop, and deliver I m plem ent readiness approach m anage the training to service know ledge transfer Change Prepare and engage Establish users processes stakeholders on partnership w ith Establish new Support stakeholder data governance NCAs and involve custom er support and operating industry transition to using service m odels representatives new MDM services Com m unication Support to stakeholders Docum entation Education 9 EU Task Force meeting - SPOR roadmap - March 2015
Thank you Any questions? 10 EU Task Force meeting - SPOR roadmap - March 2015
Supporting slides 11 EU Task Force meeting - SPOR roadmap - March 2015
Roadmap high level activity plan 12
Referential MDM high level activity plan 2015 2016 Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Q3 Q4 MDM Delivery Define services and Establish KPIs/SLAs with Support NCAs/MAHs/others to map data NCA engagement - MDM and enhance usage usage scenarios "R" goveranance monitoring & alerting Develop competency model Define & assign roles / Establish Referential Define for data mgmt responsibilies Management Service (RMS) collaboration Process model with stakeholders User guides & data mgmt process System / acceptance updated testing Change management, communications, training services, quality assurance Create inventory Create/Update data Copy CVs for Migrate CVs Migrate remaining CVs of current CVs (1) classification model testing Data Add CVs Add remaining CVs Create "R" data model IDMP 11239/40 IDMP 11238 Catalogue source Capture high level Detailed Install MDM Configure and target requirements "R" design system MDM system systems using each CV Create new Improve integration with Define MDM access & Design MDM system archiecture API external data providers security requirements System Design security Integrate with Document "As-Is" Define MDM Create model architecture architecture new UI central IAM RMS Live Design interaction model for external systems Procurement process (licences and professional services) NCA Impacts Review management processes and 3 3 security controls Review of requirements for new Plan to be shared with NCAs services and interfaces Data management user interface preview Piloting of new services 3 3 Earliest date to go-live with new services (for early adopters) New EUTCT UI (production) & Old UI removed (To be reviewed in Q2-2015) Improved list management Planning, training & change management 3 3 Industry Impacts Engagement with industry (details TBC) Access provided - system and UI Dependencies MDM Supplier(s) engaged 13 Central IAM Services available (2)
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