EMA SPOR master data management roadmap

Transcription

1 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

2 Roadmap and the overall EMA strategy Roadmap approach Roadmap developed to meet EMA business priorities and provide stakeholder benefits Initial analysis based on EMA consultation, NCA input and industry position paper 1 Stakeholder engagement High level approach for delivering SPOR services agreed by EMA leadership Based on principles agreed by the EU Telematics workshop (Feb 2015): -Simplicity, phased approach & show value with each phase Implementation EMA Referential and Organisation 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 stakeholder engagement 1 1. Principles for the implementation of ISO IDMP standards for EudraVigilance and development of a roadmap, EFPIA, 2014

3 Benefits of roadmap implementation Holistic as part of EU philosophy services integrated with stakeholder business processes Benefits Strategic Consolidated data governance Partnership with stakeholders Data as an EU asset Process orchestration Easier implementation of new initiatives (IT agility) Tactical Integration with more applications and processes Full SPOR implementation Limited initial scope Engage stakeholders Establish stewardship Implement full S, P and O services Full medicinal product life cycle (Human & Vet) Gain experience Implement R service Start measuring progress Compliance with legal requirements Foundational Efficiency & Compliance Effectiveness 2020+

4 Practical applications of services Short/Medium term Pharmacovigilance ICSR and Art. 57 data submissions Clinical Trials legislation Clinical Trials portal & database Regulatory submissions eaf, Referrals, PSUR repository, ectd, Gateway, Single submission portal Long term Falsified Medicines legislation EudraGMDP support Future initiatives eprescription Other regulatory submissions Scientific Advice/Orphan/Paediatrics applications, Veterinary products 3

5 Critical success factors Well defined & robust governance models Investment and preparation for change ISO IDMP technical specifications adopted SPOR implementation critical success factors Alignment of data, processes & systems Data enrichment for IDMP compliance Organisation awareness of services End user acceptance of services 4

6 services and stakeholder readiness Services Description Registration and maintenance of master data Establishment of the processes and technology capability for EMA and relevant stakeholders to participate in the registration and maintenance of the master data Service provided will be based on the agreed operating model within the EU as well as the EMA Access and exchange of data Access to data may be provided systematically via system interfaces, or/and via web user interfaces. Interfaces will need to be ISO IDMP compliant and enable data exchange and integration across systems. Stakeholders consuming these EMA services will require support in the form of: Customer services o Guidance documentation o Training o Direct helpdesk support 5

7 services and stakeholder readiness Area Requirement from stakeholders Technology 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 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. 6 Processes People Early engagement with EMA for change management activities during the development of 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 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

8 A phased approach for the implementation Current state Transitional state Future state Stepwise, iterative implementation projects Data consolidation and integration Change management Partnership with industry and NCAs 7

9 Roadmap high level activity plan 8

10 Change management planning Change Preparation Organisational Alignment Knowledge Transfer Training Assess Agency, NCA and industry readiness Prepare and engage stakeholders on data governance and operating models Align stakeholders with goals and approach Establish partnership with NCAs and involve industry representatives Plan, design, execute, and manage the knowledge transfer processes Support stakeholder transition to using new services Plan, design, develop, and deliver training to service users Establish new customer support service Implement Change Communication Support to stakeholders Documentation Education 9

11 Thank you Any questions? 10

12 Supporting slides 11

13 Roadmap high level activity plan 12

14 Referential high level activity plan Delivery Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Q3 Q4 NCA engagement - usage scenarios "R" Define services and goveranance Establish KPIs/SLAs with monitoring & alerting Support NCAs/MAHs/others to map data and enhance usage Process Define collaboration model with stakeholders Develop competency model for data mgmt Define & assign roles / responsibilies User guides & data mgmt process updated Establish Referential Management Service (RMS) System / acceptance testing Change management, communications, training services, quality assurance Data Create inventory of current CVs (1) Create/Update data classification model Create "R" data model Copy CVs for testing Add CVs IDMP 11239/40 Migrate CVs Add remaining CVs IDMP Migrate remaining CVs Catalogue source and target systems using each CV Capture high level requirements "R" Define access & security requirements Detailed design Design system archiecture Install system Create new API Configure system Improve integration with external data providers System Document "As-Is" architecture Define architecture Design security model Design interaction model for external systems Create new UI Integrate with central IAM RMS Live Procurement process (licences and professional services) NCA Impacts Review management processes and security controls Review of requirements for new services and interfaces Data management user interface preview Plan to be shared with NCAs Piloting of new services 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 Industry Impacts Engagement with industry (details TBC) 13 Access provided - system and UI Dependencies Supplier(s) engaged Central IAM Services available (2)

15 Substance high level activity plan Delivery Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Q3 Q4 Q1 Q2 Q3 Q4 Agree group to define EU operating model(s) & define governance Define & agree operating model EU & international (across regulators and industry) Develop competency model for data mgmt 'S' Support NCAs/MAHs/others to map data and enhance usage Procure professional services Implement KPIs/SLAs with monitoring & alerting Optimise and integrate EMA 'S' business processes Process Define business services Capture NCA requirements Define KPIs & SLAs Define & assign EMA roles / responsibilies Create EU guidance documentation, training and support material Document "as-is" architecture across processes, data and systems Define EMA extensions to IDMP (processes/lifecycle) Change management, communications, training services, quality assurance Initial substance Update data data migration classification and analysis security model Live 'S' Data Data profiling (inc gap analysis and mapping xevmpd to IDMP) Clean/Enrich/Migrate substance data Final S data migration Create initial data model - substance Finalise data model System Catalogue source and target systems using Substance data & services (inc external) On-going analysis of FDA's Open-SRS Define architecture req's for 'S' Review system arch. and model design for 'S' Design interaction model for external systems Update access & security requirements Configure Implement Identity Integrate EUTCT system & Access integration with Create new Modify main Modify secondary Create new UI API applications impacted applications Implement workflow for FDA data integration data management System / acceptance testing NCA Impacts Define governance and operating model(s) Review requirements for new services and interfaces New UI (preview) for 'S' IDMP compliant New UI and system interface - pilot New UI and system interfaces - production 3 Planning, training & change management Industry Impacts - TBC Engagement with industry (details TBC) Access provided - system and UI 3 Dependencies Infrastructure Installed and configured for 'R' Live for 'R' IDMP Implementation Guides Earliest date exepcted to be ready for system design Latest date exepcted to be ready for system design Publication 14 HL7 message specification Identity and Access Management Services Earliest date exepcted to be ready for system design Latest date exepcted to be ready for system design Publication Available for integration and testing

16 Product high level activity plan Delivery Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Q3 Q4 Q1 Q2 Q3 Q4 Define & agree operating model EU & international (regulators & industry) Agree scope & strategy of implementation Develop competency model for data mgmt Procure professional services Implement KPIs/SLAs with monitoring & alerting Support NCAs/MAHs/others to map data and enhance usage Optimise and integrate "P" business processes Process Develop & agree high level implementation plan Define business services Define NCA service requirements Define & assign EMA roles & resp. Define KPIs/SLAs System / acceptance testing Create EU guidance and support material Change management, communications, training services, quality assurance Define EMA extensions to IDMP (processes/lifecycle) Initial product data migration analysis Data Create initial data model - product Initial product data migration Finalise data model Clean/Enhance/Migrate product data Final P data migration Update data classification and security model Update access & security requirements 'P' Update system archiecture and security model design for PMS Configure system Implement Identity & Access integration part-integrate EV with Define architecture req's Design interaction model for external systems Create new API Create new UI Modify main applications Modify secondary applications System Catalogue source and target systems using Product data & services (inc external) Implement workflow Document "as-is" architecture Live 'R' Live 'S' Live 'P' NCA Impacts New UI (preview) - IDMP compliant New UI and API (pilot) 3 3 New UI (production) Industry Impacts Engagement with industry (details TBC) Access to be provided - system and UI (TBC) Dependencies Infrastructure Installed and configured for 'R' Live for 'R' Live for 'S' IDMP Implementation Guides Earliest date exepcted to be ready for system design Latest date exepcted to be ready for system design Publication HL7 message specification Earliest date exepcted to be ready for system design Latest date exepcted to be ready for system design Publication 15 Identity and Access Management Services Available for integration and testing

17 Organisation high level activity plan Delivery Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Q3 Q4 Q1-2 Q3-4 NCA engagement - usage scenarios "O" Define services and goveranance Define KPIs/SLAs Optimise and integrate 'O' business processes Support NCAs/MAHs/others to map data and enhance usage Process Define collaboration model with stakeholders Procure professional services Develop competency model for services Implement KPIs/SLAs with monitoring & User guides & data mgmt process updated Establish Iteration 1 Organisation System / acceptance testing Establish Iteration 2 Organisation Optimise and integrate 'O' business processes Establish Iteration 3 Organisation Optimise and integrate 'O' business processes Establish Iteration 4a Organisation Establish Iteration 4b Organisation Optimise and integrate 'O' business processes Define & assign roles / responsibilies Change management, communications, training services, quality assurance O1 Design, build and test cycle Data Create extensible O data model Create operating model for data registration Detailed data analysis Finalise/extend data model Clean, consolidate and create data from reference sources Initial O1 data migration Final O1 data migration O2 Design, build and test cycle O3 Design, build and test cycle O4a Design, build and test cycle O4b Design, build and test cycle Update data classification and security model O2 Detailed analysis O3 Detailed analysis O4a Detailed analysis O4b Detailed analysis Catalogue source and target systems Capture high level requirements "O" Detailed design Configure Define access & security requirements Design interaction model for external systems Create new API part-integrate eaf with System Document "As-Is" architecture Define architecture Design security model Create new UI Integrate with central IAM services part-integrate eaf, Siamed with part-integrate CT and EV with part-integrate eaf, Siamed with part-integrate eaf with Design system architecture Milsetones Live 'R' Live O1 Live 'S' Live O2 Live 'P' Live O3 Live O4a Live O4b NCA Impacts Review management processes and security controls Review of requirements for new services and interfaces Data management user interface preview Piloting of new services Earliest date to go-live with new services (for early adopters) Planning, training & change management Industry Impacts Engagement with industry (details TBC) Access provided - system and UI Dependencies Supplier(s) engaged 16 Central IAM Services available (1)