SPOR User On-boarding and Access Guidelines

Update regarding RMS and OMS system changes to SPOR liaisons for an agency of the European Union. Information includes technical delivery, business delivery, on-boarding plans, functionality roll-out, and access guidelines for stakeholders using SPOR services. Details on user roles, login requirements, and functionalities available to different user types are outlined.

• SPOR
• User On-boarding
• Access Guidelines
• Stakeholders
• System Changes

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1. RMS & OMS Update to SPOR change liaisons An agency of the European Union

2. RMS and OMS go-live Technical delivery: RMS/OMS planned go-live 19 June 2017 subject to confirmation RMS RMS lists available for search and export RMS change request and other functionality ready to be used to support the mapping activity started in 2016 by NCAs OMS OMS functionality available but subject to the planned improvements over summer releases OMS dictionary content being reviewed to address feedback received during UAT and planned to be released with the summer releases OMS dictionary content is limited to NCA organisations at the go-live, (MAHs, MAAs, MRL data available in Q3 (see slide 10) Business delivery: EMA Data Stewards team ready to support data management and business queries meet the team (slide 12) Process and SLAs in place 2

3. SPOR on-boarding plan RMS and OMS user on-boarding NCAs on-boarding starts in June Industry on-boarding starts in October RMS and OMS functionality roll-out NCAs use of RMS (mostly for Change Requests (CRs)) as of June Industry use of RMS as of October NCAs & Industry use of OMS as of October OMS content roll-out Q3, Q4 2017 Q1, Q3 2018 3

4. Access to SPOR Stakeholders access IdentityIQ (IIQ) SPOR services Stakeholders can use SPOR services depending of their user role (Guest user, Unaffiliated user, NCA user, NCA translator, NCA Super User, Industry user, Industry Super User) Guest Users can browse public information in SPOR (login is not required) IIQ - central point for managing the user access to EMA s systems (inc. SPOR) New users will need go to IIQ to self- register Once the account is activated they can request the relevant SPOR role IIQ is also used to request SPOR user role Super Users (SU) can approve other Users roles for their organisation via IIQ Jira service desk needs to be used for submitting docs for the 1st Super User (SU) of the Organisation To use SPOR services stakeholders need to log in the SPOR portal using a username and a password which is obtained through IIQ EMA Service Desk IIQ SPOR user role Login to SPOR portal to use SPOR services Document submission for 1st SU via EMA ServiceDesk E-mail confirming Account Activation 4

5. SPOR user roles vs. functionality Guest user Unaffiliated user Industry user NCA user NCA Translator Industry Super user NCA Super user Login Not Login required Login required Login required Login required Login required Login required required View Public data Yes Yes Yes Yes Yes Yes Yes View Restricted data No No No Yes Yes No Yes Search data Yes Yes Yes Yes Yes Yes Yes Download data No Yes Yes Yes Yes Yes Yes Submit Change Request (CRs) No Can submit CRs in OMS for a new org. (1 pending request at a time) Yes Yes Yes Yes Yes Translations No No No No Yes No No Permission to authorise users No No No No No Can Can authorise Industry users authorise NCA users 5

6. RMS and OMS user on-boarding 2017 2018 User Roles Jun Jul Aug Sep Oct Nov Dec 2018 Guest User Non-Registered users have Guest User access only Unaffiliated User Registered users will be given Unaffiliated User role by default NCA Super User registration and authorisation NCA Super User NCAs NCA User & NCA Translator NCA User & NCA Translator registration and authorisation Industry Super User registration and authorisation Industry Super User Industry Industry Users Industry Users registration and authorisation 6

7. RMS core functionality & services Data API Change Requests New API (Application Programming Interface) for NCAs and Industry to receive data from RMS and submit data to RMS Backward compatible API for NCAs Lists from EUTCT New lists for OMS & PMS EDQM Lists & U&M Lists (ISO standard lists) EV lists (New) EV Terms (New) Submitting requests for New /Updated lists and terms via RMS web interface Translations Preferences View, export, search Translations done directly via RMS (one by one) or via a bulk upload NCAs only functionality New capabilities to subscribe and receive notifications of changes, to tag terms and save searches Functionality to view RMS Lists and Terms Simple and advanced search Help and Support New self-registration process to obtain access to SPOR, Customer support, RMS user guide New or improved functionality, content comparing to EUTCT Area where functionality is not be fully working but this not prevents the business process to be executed

8. RMS content Key Points at which new Referentials data is added RMS go-live Q2 2017 Start submitting Change Requests (CRs) for Referentials Note: EUTCT will continue for Substance lists, until SMS is delivered. At RMS go-live NCAs can use backward compatible EUTCT APIs. October Date tbc CRs - Industry CRs - NCAs only Referentials data will be expanded over time with Lists to support ISO standards for products and substances: ISO 11238 Referential data to support substance registration and ISO 11615 Referential data to support products Lists migrated from the EUTCT (e.g. Shelf life type, Target species) New Lists to support OMS (e.g. party classification) Updated Lists (partially at go-live) for ISO 11239 (pharmaceutical dose form, routes of administration and packaging) ISO 11240 (units of measurement) (these are flat Lists from EUTCT which have been structured with full ISO data elements) Further Lists can also be added upon request, usually as a result of the introduction of new Telematics systems

9. OMS core functionality & services Data Change Requests API New API (Application Programming Interface) for NCAs and Industry to receive data from OMS Submission of data via CRs fully functional on the next release NCA organisations at go live MAHs (NAP-H/CAP-H&V); MAAs (CAP-H&V); MRL Applicants in Q3-17 Sponsors (NAP/CAP-H) in Q4-17 Manuf. (CAP-H&V) in Q1-18 Manuf. (NAP-H&V) in Q3-18 Documents Submitting requests for New /Updated organisations via OMS web interface (fully functional on the next release) Search & View Export Search Organisation and Locations published View details of Organisations and Locations Open, download documents Fully functional on one of the next releases Help and Support New self-registration process to obtain access to SPOR, Customer support, OMS user guide Area where functionality will be fully functional on the next release

10. OMS content Key Points at which new organisation data is published in OMS Mapping of Organisations data against OMS and submission of Change Requests (CRs) for Organisations (*) subject to planning OMS go-live Q2 2017 OMS eAF Integration (*) OMS Integration with XEVMPD (*) RMS & OMS CESSP MAA integration (*) CESSP MAA Enforcement Q3 2017 Q4 2017 Q1 2018 Q3 2018 Date tbc Product data comparison exercise Sponsors: (H) CAPs & NAPs Manufacturers: (H+V) NAPs NCAs/Regulatory Authorities Manufacturers: (H+V) CAPs Additional Organisation data will be added in future, its prioritisation will be defined at a later stage - MAHs: (H+V) CAPs & (H) NAPs - MAAs: (H+V) CAPs - MRL applicants (Vet) 10

11. RMS and OMS functionality roll-out 2017 2018 Jun Jul Aug Sep Oct Nov Dec 2018 Start using RMS: e.g. Search; Export, Submit Change Requests (CRs), Translations, Preferences, Documents, New API, Backward Compatible API NCAs Start using OMS: e.g. Search; Export; Submit CRs, Documents, API Start using RMS: e.g. Search; Export, Submit CRs, Preferences, Documents, API Industry Start using OMS: e.g.Search; Export; Submit CRs, Documents, API 11 SPOR functionality Industry NCAs

12. EMA data stewards meet the team 1st line support Joanna Borkowicz Pedro Batista 2nd line support Kepa Isabel Chicharo Nuno Lopes Katerina Bursikova Jaume Gonzalez Amutxastegi Cristina Rusu Elena Nastac Dimitrios Daravigkas Debora Martins EMA data stewards - specialised EMA team that will manage SPOR data and provide support to stakeholders 12

13. SPOR SLAs Indicative RMS and OMS SLAs, based on experience RMS requests aimed to be validated within 2-5 working days and approved within 1-2 months OMS standard requests aimed to be approved within 5 working days In future the SLAs will be reviewed as these are new services where the workload still need to be verified SLAs will be discussed with stakeholders as SPOR data will be consumed by other systems Some additional information of the RMS and OMS SLAs (draft) are listed in the annex 13

14. Impacts at go-live At RMS (Referential Management System) and OMS (Organisation Management System) go-live, submission processes will continue as before and there will be no immediate process changes for stakeholders Some changes in the current submission processes are being explored and consultation is taking place with stakeholders on these e.g. changes in Art 57 submission process are being discussed with Art.57 IWG. Consultation is also taking place with eAF group to prioritise and plan for eAF integration with OMS (it is already integrated with EUTCT/RMS) From SPOR go-live to SPOR becoming mandatory in a given regulatory process there is normally a period which is not less than 6 months. Stakeholders (NCAs and Industry) are requested to carry on with agreed activities such as mappings and submitting change requests 14

15. SPOR on-boarding vs stakeholder activities 2017 2018 2019 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 RMS Go-live Go-live OMS RMS & OMS NCA data MAH data Sponsor data CAP NAP Manufacturers Manufacturers RMS & OMS xEVMPD Integration RMS & OMS CESSP (MAA) Integration RMS & OMS CT Portal Integration RMS & OMS eAF Integration NCA mapping of Referentials NCA user registration NCA submit RMS CRs R & O Network Activities NCA mapping of Organisations Industry Super User (SU) registration Ind. SU Industry User registration Industry mapping of Referentials & submit RMS CRs Industry mapping of Organisations NCA and Industry submit OMS Change Requests-MAH NCA/Industry submit OMS CRs - CAP Manufacturers NCA/Industry submit OMS CRs NAP Manufacturers

16. Thank you 16

17. Annex 17