1. RMS & OMS Update to SPOR change liaisons

2. RMS and OMS go-live Technical delivery: Business 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

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

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)
To use SPOR services stakeholders need to log in the SPOR portal using a username and a password which is obtained through IIQ
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
EMA
Service
Desk
IIQ
SPOR user role
confirming
Account Activation
Document submission for
1st SU via EMA ServiceDesk
Login to SPOR portal to use SPOR services

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

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

7. RMS core functionality & services
Data
Lists from EUTCT
New lists for OMS & PMS
EDQM Lists & U&M Lists (ISO standard lists)
EV lists (New)
EV Terms (New)
API
New API (Application Programming Interface) for NCAs and Industry to receive data from RMS and submit data to RMS
Backward compatible API for NCAs
Change Requests
Submitting requests for New /Updated lists and terms via RMS web interface
Translations
Translations done directly via RMS (one by one) or via a bulk upload
NCAs only functionality
Preferences
New capabilities to subscribe and receive notifications of changes, to tag terms and save searches
View, export, search
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
Upload translations
Subscription notifications
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 RMS go-live Q2 2017 October Date tbc CRs - NCAs only
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
CRs - NCAs only
CRs - Industry
Date tbc
Referentials data will be expanded over time with Lists to support ISO standards for products and substances: ISO – Referential data to support substance registration and ISO – Referential data to support products
Further Lists can also be added upon request, usually as a result of the introduction of new Telematics systems
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 (pharmaceutical dose form, routes of administration and packaging)
ISO (units of measurement)
(these are flat Lists from EUTCT which have been structured with full ISO data elements)

9. OMS core functionality & services
Data
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
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
Change Requests
Submitting requests for New /Updated organisations via OMS web interface (fully functional on the next release)
Documents
Open, download documents
Search & View
Search Organisation and Locations published
View details of Organisations and Locations
Export
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
Upload translations
Subscription notifications
Area where functionality will be fully functional on the next release

10. OMS content OMS go-live Q2 2017 13 April 2018 OMS–eAF Integration (*)
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
Product data comparison exercise
Date tbc
NCAs/Regulatory
Authorities
Sponsors:
(H) CAPs & NAPs
Manufacturers: (H+V) NAPs
Manufacturers: (H+V) CAPs
- MAHs: (H+V) CAPs & (H) NAPs
- MAAs: (H+V) CAPs
- MRL applicants (Vet)
Additional Organisation data will be added in future, its prioritisation will be defined at a later stage

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

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

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

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

15. R & O Network Activities Industry Super User (SU) registration
13 April 2018
SPOR on-boarding vs stakeholder activities
2017
2018
2019 Q1 Q2 Q3 Q4
RMS & OMS
R & O Network Activities
RMS
Go-live
OMS
Go-live
NCA
data
MAH
data
Sponsor
data
CAP
Manufacturers
NAP
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
NCA mapping of Organisations
Ind. SU
Industry Super User (SU) registration
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

17. Annex

18. RMS SLAs in detail - DRAFT
Add Term
Update Term
Delete term
Add list
Update list
Return Request
Validation
Within 2-5 working days (w/d)
Within 3 w/d
Within 5 w/d
Within 15 w/d
N/A
Approval
Within 1 month when owned by RMS
No approval SLA when owned by external providers
Within 2 month when owned by RMS
Within 2 month
Outcome
- A provisional Term is available for use if the request if validated
- The Term becomes current (final) if the request is approved
- The Term is only updated if the request is approved
- The Term is not physically deleted rather its status is updated to “Non-current” if the request is approved
- The List is available for use if the request is approved
- The List is updated if the request is approved
- The requestor has 2 weeks to reply back with additional information required, after which point the request is rejected

19. OMS SLAs in detail - DRAFT
Add
Org./Loc.
Loc(s)
Update
Org.
Loc.
Delete
Org./Loc
Add Org./Loc. due to a split
Returned on hold
Approval
Within 5 working days (w/d)
Within 5 w/d
Within 10 w/d
Within 5 w/d after reply from the requestor
Outcome
The Org./
Loc. is available for use if the request is approved
The Loc. is available for use if the request is approved
The Org. is updated if the request is approved
The Org. is not physically deleted rather its status is updated to “Inactive” if the request is approved
The Org./Loc. is available for use if the request is approved
The requestor has 2 weeks to reply back with additional information required, after which point the request is rejected