Organisations Presented by: Kepa Amutxastegi Project Manager for - PowerPoint PPT Presentation

Organisations Presented by: Kepa Amutxastegi Project Manager for OMS An agency of the European Union

Topics 1. Project status 2. Organisations Roll-out plan OMS User Acceptance Testing (UAT) 3.

Status update Key achievements since last EUNDB/Taskforce reporting (September 2015) Project Status 1. Business Case approved in December by EMA Executive Board 2. OMS subgroup tested the implementation of Phase I operating model based on real business scenarios 3. Work has begun to involve veterinary stakeholders in the SPOR activities (via EUNDB, ISO IDMP TF) Amber 4. Change management / communication activities underway to support the SPOR projects Key risks & issues: 1. EMA has limited resources for the project - Additional support required from the network ( Issue ) 2. Last minute registration requests before product iteration 1 enforcement – EMA won’t cope with volumes ( Risk ) 3. IAM solution integration architecture is still uncertain ( Issue ) Activities since last f2f EUNDB/Taskforce (September 2015) Upcoming activities • Final sign-off of system use cases, logical data model, process models and • Analysis and design phase almost complete detailed requirements underway • Implementation phase started in January • Completion of draft API interface specification • Roll-out plan for NCAs / Industry prepared with EUNDB, showing: • Endorsement of Phase I Operating Model by EUNDB / ISO IDMP TF in Feb • What organisational data requires mapping • Continue development of the UAT plan for OMS • Which use cases drive the mapping • Presentation of the OMS Roll-out plan at the HMA in February • When the activity should start • Dedicated webinars to be delivered to IT Directors February / March to present • OMS Subgroup conducted activities such as discussing, reviewing and the OMS roll-out plan and discuss mapping considerations endorsing the logical data model, requirements and solution in general Project milestones (until end 2016) Q1 2016 Q2 2016 Q3 2016 Q4 2016 OMS services public go live MDM configuration UAT (external Roll-out plan for OMS Internal stakeholders) (Installation and go live Initial organisation dictionary available configuration of all • Web interface /API • environments) • Data stewardship capabilities 2 Service Desk • • New organisation registration process

Status update – agreed operating model Phase I - Organisations Operating Model – Implemented as part of the first OMS project Scenario applicable when the regulatory submission takes place with an NCA Pre-Registration of Organisation in the EU Organisation Hub Applications/information sent as part of regulatory activities Request Industry Organisation registration or Submit application update Message containing: NCA_org_ID & <EU_Loc_ID> EU_Loc_ID and <Organisation data> organisation data <Other IDs> (& other IDs) etc. If not registered, assign NCA_org_ID and validate EU_Loc_ID and against EU_Loc_ID organisation data (& NCA other IDs) Request for organisation registration or update EU_Loc_ID and organisation data (& other IDs) Register and issue EU_Loc_ID & Org_ID EMA Request for organisation registration or update Publish data in the organisation dictionary MDM (EU Hub) 3

Status update – System Use Cases Impacting EMA, NCAs • 14 Use Web and industry Portal & cases API Use case • 8 Use Models MDM/IDQ cases 3 Use cases Impacting only EMA • 26 Use IDD cases 4

Organisations Roll-Out Plan An agency of the European Union

High Level Roll-out Plan ROLL OUT - HIGH LEVEL PLAN 2016 2017 2018 2019 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 EMA - SPOR EUTCT & RMS Maintenance of RMS lists and release of new lists RMS xEVMPD OMS xEVMPD Expansion of dictionary with additional organisation data OMS MAHs; MAAs; MRL applicants; Sponsors Reg Auth Manuf - CAPs Manuf - NAPs TBD: CROs; CT site; Academia; Hospitals; PhVig MF location; etc MA & MRL contacts EMA - EU Programmes PMS & PMS & Data Integration SMS SMS New CT Clinical Trials Portal Pharmacovigilange E2BR3 SSP SSP ! ! eSubmissions MA var EVVet3 Veterinary Vet EU P DB EU DB Manuf & DB Sale & Dist Other Wholesale Dist antimicrobials NCA/Industry Tasks Participate/Follow-up SPOR projects Project Participation Consume SPOR Commitments & Enforce TOM Analyse & adapt process - enforce TOM; implement Process sync Analyse & adapt systems - mapping vs substitution; Systems implement sync Data data mapping & request new/updated data 6

Organisations Data Roll-out Plan What data to Systems to source data The use cases i.e. When to map When to request Approval period map against from drivers for the mapping new/updated terms Mapping / Telematics/external OMS data Supporting CAPs Supporting NAPs Use cases 2016 2017 2018 Validation systems MAA - eAF/SSP 2018? e-Health Care - which Pharmacovigilance - Clinical Trials - New Inspections - TBD?? Support to 11615 - Support to 11238 - Veterinary - 2019? projects & when? CT portal 2017? PMS Q1/2 2018 SMS Q1/2 2018 E2BR3 2018? Organisation/I Total OMS Data Human Veterinary Human Veterinary xEVMPD EudraGMDP Data volumes ndividual Mar-16 May-16 Mar-17 May-17 Mar-18 May-18 Feb-16 Aug-16 Sep-16 Nov-16 Dec-16 Feb-17 Aug-17 Sep-17 Nov-17 Dec-17 Feb-18 Aug-18 Sep-18 Nov-18 Dec-18 Jan-16 Apr-16 Jun-16 Oct-16 Jan-17 Apr-17 Jun-17 Oct-17 Jan-18 Apr-18 Jun-18 Oct-18 Jul-16 Jul-17 Jul-18 MAH Organisation Yes Yes Yes No x 2-Medium x x x x x x x 7 MA Applicant Organisation Yes Yes No No 1-Low x x x 3 MRL Applicant Organisation n/a Yes n/a n/a 1-Low x 1 Sponsor Organisation Yes No Yes No x 2-Medium x x x ?? x 4 Manufacturer Organisation Yes Yes No No x 3-High x x x x x ?? 5 Manufacturer Organisation No No Yes Yes x 3-High x x x x x ?? 5 Regulatory Authority Organisation 1-Low x x ?? x x x 5 CRO Organisation 2-Medium x ?? 1 ? ? ? ? ? ? ? ? ? ? ? Clinical Trial site Organisation 2-Medium x ?? 1 ? ? ? ? ? ? ? ? ? ? ? Academia Organisation 1-Low x ?? 1 ? ? ? ? ? ? ? ? ? ? ? Hospitals Organisation 1-Low x 1 ? ? ? ? ? ? ? ? ? ? ? PhV Master file Organisation ?? 1-Low ?? x 1 location MA regulatory contacts Individual x x No No x (QPPV) 2-Medium x x 2 ? ? ? ? ? ? ? ? ? ? ? MRL applicant contact Individual n/a x n/a n/a 1-Low 0 Sponsor contact Individual ?? ?? ?? ?? ??? 1-Low x 1 0 • Mapping should start ASAP against xEVMPD for MAH and Sponsors • Mapping of other organisations data can start only once it is available in the dictionary • Mapping/requests need to complete ideally 3 months before implementation of intended Use case • All major programmes have deliveries before 2019 -> to map all data work needs to start ASAP 7

Organisations Roll-out plan What When Details • Participate/Follow-up OMS project • Throughout 2016 • OMS Subgroup will need to continue work throughout 2016 and at lesser intensity through 2017 to support product and substance iteration 1 implementation • Commitments • By end February • Each NCA to nominate a contact point for SPOR (to be provided to IT Directors in preparation Consume Organisation data & of the Telematics Forum) • enforce operating model Contact Points (EMA, NCAs • and industry) • Adapt systems & processes • From 2016 Analyse impact on existing processes to support: • Implementation of the operating model including pre-registration of organisations data • Transformation / enrichment / mapping of data locally • • Data consumption / synchronisation with OMS Choose implementation approach: continuous mapping between own system & SPOR vs • substitution of own data by new SPOR references • Map / Validate data • Start ASAP vs • From now until Nov 2016 map: Mapping / validation of MAH and Sponsors ( xEVMPD ) xEVMPD • From Dec 2016 – Mar 2018 : Mapping / validation of content of dictionary: MAHs full list ( in OMS dictionary ) • • Sponsors, Regulatory Authorities, Manufacturers, etc. (added in the dictionary during Dec-2016 and Dec-2017) ( in OMS dictionary ) • New process to create new/update • From November • From Dec 2016 - Feb 2017 request data for: MAH (NAPs/CAPs) + MA applicant (CAPs), MRL organisation data 2016 Applicant • From Apr 2017 – Jun 2017 request data for: Sponsor & Regulatory Authority • From Jul 2017 – Sep 2017 request data for: Manufacturers (CAPs) • From Jan 2018 – Mar 2018 request data for: Manufacturers (NAPs) • Others…. TBC (CROs, CT sites, PhV Master file location, Academia, Hospitals, etc.) 8

OMS UAT Presented by: David Scanlon (AstraZeneca) An agency of the European Union