Referentials Management Service RMS and Organisations ...

5 July 2017 EMA/307181/2017 Information Management Division

Referentials Management Service (RMS) and Organisations Management Services (OMS) user onboarding plan

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5550 Send a question via our website www.ema.europa.eu/contact

An agency of the European Union

© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

Table of contents 1. Launch of Referential Management Service (RMS) and Organisations Management Services (OMS) ....................................................................... 3 2. SPOR user roles ....................................................................................... 4 3. RMS and OMS user on-boarding............................................................... 7 4. Overview of the RMS & OMS key functionality at go-live ......................... 9 4.1. RMS core functionality and services ........................................................................ 9 4.2. OMS core functionality and services ...................................................................... 11 4.2.1. OMS data roll-out plan ..................................................................................... 12

5. RMS and OMS Service Level Agreement (SLA) ....................................... 13 6. Impacts at RMS and OMS go-live ........................................................... 14

Referentials Management Service (RMS) and Organisations Management Services (OMS) user onboarding plan EMA/307181/2017

Page 2/15

1. Launch of Referential Management Service (RMS) and Organisations Management Services (OMS) A first version of ISO IDMP compliant (11239 & 11240) Referential Management Services (RMS) and Organisation Management Services (OMS) was deployed in production on 19 June and is now live. The scope of the release included data content, functional capabilities and a range of services: •

a single source or Referentials data including updated lists from EUTCT 1 (these are flat lists which have been structured with full ISO data elements), lists migrated from EUTCT and new lists to support the OMS;

•

capabilities to standardise, cleanse, consolidate and publish a single list of organisations with their physical locations (also known as organisation dictionary). At initial launch of the OMS the list of organisations will contain a limited set of data, which will be expanded over time;

•

Referential and Organisation data accessible via the SPOR web portal 2 and programmatically via the API (Application Programming Interface);

•

a new process for industry and national competent authorities (NCAs) to register/update Organisation and Referential data;

•

a specialised team of EMA data stewards to oversee the management of data and provide support to stakeholders.

The launch of the RMS and OMS in June 2017 does not immediately change any regulatory submission processes. However, EMA is consulting stakeholders on the benefits of using the SPOR services for different regulatory procedures. This will enable them to support regulatory submissions using systems such as: electronic application form eAF 3, Common European Single Submission Portal (CESSP) 4. EMA will invite national competent authorities (NCAs) and industry stakeholders to register their RMS and OMS users, starting with Super Users who can authorise the registration of further users from the same organisation. However, the timetable is different for different stakeholders: •

National competent authorities: EMA invited national competent authorities to begin registering their Super Users and to use RMS from June 2017: −

These users should only begin using OMS from October 2017, because it will contain a limited set of data at the initial launch,

•

Industry: EMA will invite industry stakeholders to begin registering their Super Users and start using RMS and OMS from October 2017.

RMS and OMS user on-boarding plan has been prepared to streamline the on-boarding of NCAs and industry users to SPOR. It explains the sequence at which stakeholders will be on-boarded to SPOR and how RMS and OMS functionality will be rolled out.

1

EUTCT - the European Union Telematics Controlled Terms (EUTCT) System SPOR portal is compatible with web browsers Internet Explorer (version 10 and above) and Chrome (version 58 and above); 3 Integration between RMS, OMS and Telematics systems, applications is subject to availability of resources at EMA and Member States 4 Integration between RMS, OMS and Telematics systems, applications is subject to availability of resources at EMA and Member States 2


Page 3/15

2. SPOR user roles In terms of SPOR there are different user roles. The user types range from a Guest User with basic access to a user who is affiliated to a particular industry or NCA organisation and can fully use the services such as register/update Referential or Organisation data, in other words submit a Change Request (CR). These user types are noted in the diagram below and briefly explained in the section beneath, in order to introduce the user on-boarding topic. For the full explanation of SPOR user roles stakeholders are advised to consult EMA SPOR User Registration Manual. This is a step-by-step guide on how to register for SPOR and request SPOR user roles. This document is published on the SPOR portal under the documents tab. Figure 1. SPOR user roles

Guest User – is a user who will not require a login in to SPOR and will be able to view and search public data (RMS: public lists and OMS: all content). Unaffiliated User – is a logged in user who is not yet affiliated or linked to a specific organisation. An Unaffiliated User will be able to view the same data as a Guest User, but will also be able to export that data. An Unaffiliated User will be allowed to submit one Change Request (CR) in the context of OMS in order to facilitate the registration of users. Industry User – is a logged in user who represents an industry organisation and has been approved by the Super User of that organisation (in other words is affiliated or linked to an industry organisation). A request for an Industry User role will have been done via the IIQ tool (Identity IQ) 5. In terms of functionality an Industry User will be able to view/download public data (RMS: public lists and OMS: all content) and submit change requests on behalf of the organisation they are affiliated to. It is important to verify that your organisation has a Super User before submitting a request in IIQ tool (Identity IQ), if your organisation does not have one, the request will be rejected by EMA. Industry Super User – is a logged in user, who, on behalf of his organisation, will approve other users from that organisation to have access to SPOR. A Super User will need to ensure that only the right users are assigned SPOR roles against their organisation. This user role also includes the revocation of these roles should the user no longer represent their organisation. The approval of users will be done via the IIQ tool (Identity IQ). It is important to note that the first Super User of an organisation will have to submit a document validating their authorisation to represent that organisation. In the absence of such proof, the request

5

IIQ tool - is a central point at EMA to manage user access to EMA’s systems (including SPOR)


Page 4/15

will be rejected by EMA. Submission of such document will need to be done via the EMA Service Desk portal (Jira) 6. In terms of SPOR functionality, Super User is a standard Industry User who can view, search, download public data (RMS: public lists and OMS: all content) and submit Change Requests. NCA User - is a logged in user who works for a national competent authority (NCA) or an organisation acting as a regulatory authority and has been approved by the NCA Super User to have access to SPOR. An NCA User will be able to view/download public and restricted data and request changes to RMS and OMS data by submitting a Change Request on behalf of their organisation. This role will be approved by the Super User of the organisation via the IIQ tool (Identity IQ). It is important to verify that the organisation has a Super User before submitting a request in IIQ tool. If the organisation does not have one the request will be rejected by EMA. NCA Translator – is a logged in user who works for a national competent authority (NCA). If the user is requesting the role of an NCA Translator they must also specify the language they will be providing translations for, in addition to the organisation name. Having an NCA User role will not be sufficient to allow the user to do translations, in order perform this task NCAs users will need to request the specific role of NCA translator. NCA Super User – this is a logged in user who works for a national competent authority (NCA) or an organisation acting as a regulatory authority and is responsible for approving other users to have access to SPOR on behalf of their organisation. An NCA Super User will need to ensure that only the right users are assigned SPOR roles against their organisation. This user role also includes the revocation of these roles should the user no longer represent their organisation. The approval of users will be done via the IIQ tool (Identity IQ). In terms of SPOR, a Super User is a standard user who can view, search, download data or submit change requests. A summary of SPOR user roles vs functionality is shown in the Figure 2 below.

6

Online EMA Service Desk for Information Technology (IT) systems


Page 5/15

Figure 2. SPOR user roles vs functionality diagram SPOR user roles Guest

Unaffiliated

Industry

Industry

NCA

NCA

NCA

User

User

Super

User

User

Translator

Super

User Login

User

Not

Login

Login

Login

Login

Login

Login

required

required

required

required

required

required

required

Yes

Yes

Yes

Yes

Yes

Yes

Yes

No

No

No

No

Yes

Yes

Yes

Search data

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Download

No

Yes

Yes

Yes

Yes

Yes

Yes

No

Can submit

Yes

Yes

Yes

Yes

Yes

View Public data View Restricted data

data Submit Change

CR in OMS

Request

for a new

(CR)

organisation. One pending request at a time

Translations

No

No

No

No

No

Yes

No

Permission

No

No

Can

No

No

No

Can

to authorise

authorise

authorise

users

Industry

NCA Users

Users

For more comprehensive information on OMS and RMS functionalities please refer to the RMS and OMS web user manuals, which are published on the SPOR portal. These are step-by-step guides describing the main functionalities available in the RMS and OMS web user interface.


Page 6/15

As outlined above, Guest Users will be able to view public information in SPOR portal and they will not require login (username and password). To be able to fully use SPOR services, such as, submit Change Requests for referential or organisation data, stakeholders will require login and the relevant SPOR role. •

New users will need to self-register in Identity IQ (IIQ) to obtain the login. After self-registration, they need to requests SPOR user role, also via Identity IQ (IIQ);

•

Users who already have an account (login) will need to request SPOR user role via Identity IQ.

Key points concerning stakeholders access to SPOR are highlighted in the diagram below. Figure 3. Identity IQ (IIQ)

3. RMS and OMS user on-boarding EMA will invite national competent authorities and industry stakeholders to register their RMS and OMS users, starting with 'Super Users' who will authorise the registration of further users from the same organisation. However, the timetable varies for different stakeholders: •

National competent authorities: EMA invited national competent authorities to begin registering their Super Users and to use RMS from June 2017: −

These users should only begin using OMS from October 2017, because it contains a limited set of data at the initial launch,


Page 7/15

•

Industry: EMA will invite industry stakeholders to begin registering their Super Users and start using RMS and OMS from October 2017.

The approach to prioritise registration of NCA users and then on-board industry users has been chosen taking into consideration the following: •

NCAs can start submitting RMS Change Requests (CRs) that resulted from mapping of Referentials (activity that has been ongoing since 2016);

•

content of the OMS dictionary will be expanded with a new set of Organisation data by Q3 2017;

•

post go-live releases planned for RMS and OMS to enhance functionality.

The RMS and OMS user on-boarding plan and functionality roll-out are shown in the diagrams below. Figure 4. RMS and OMS on-boarding of users


Page 8/15

Figure 5. RMS and OMS functionality roll-out

4. Overview of the RMS & OMS key functionality at go-live 4.1. RMS core functionality and services RMS replaces EUTCT (EU Telematics Controlled Terms) as the central repository and provider of Referentials. RMS brings new and improved functionality over EUTCT (these are indicated in Figure 6 below). In terms of content RMS will go live with the following lists: •

lists migrated from EUTCT;

•

new lists for OMS;

•

EDQM lists and Units of Measurement (U&M) lists (these are ISO IDMP standard lists);

•

EV lists (new);

•

EV terms (new).

RMS data can be accessed directly via the SPOR portal or programmatically via API (Application Programing Interface). There is a new API as well as the EUTCT backward compatible API, which national competent authorities (NCAs) can use.


Page 9/15

The change requests are in full working capacity and the NCAs can start using this functionality for submitting changes, which resulted from the mapping 7 of Referentials. Industry can start using the change requests as of October 2017 when EMA begins on-boarding of industry users. NCAs can do translations exactly the same way as they used to do in EUTCT, which means one term at a time, but the improvement, in terms of bulk upload, will be implemented in a subsequent RMS release. Preferences are new capabilities previously not available in EUTCT, they can be used to subscribe and receive notifications of change requests, or users can save frequently used searches or tag terms. There are still some improvements to be done during subsequent release to improve subscriptions. Export and search functionality are working well and users can view lists and terms and perform simple or advanced searches. RMS services and core functionality are shown in the diagram below, indicating areas where functionality has improved over EUTCT or is new and showing any areas which may not be fully working yet or that are expected to be improved during the next release. Figure 6. RMS core functionality and services

7 Data mapping can be described as the process of matching data elements between two (or more) distinct sets of data. Data mapping will address the issue of different vocabularies across the network and will support integration with Telematics systems, therefore it is considered as one of the critical activities to the successful delivery of SPOR.


Page 10/15

The diagram below provides an overview of Referential lists at go-live, indicating from which point onwards NCA and industry stakeholders can start submitting the change requests for Referentials. Figure 7. Content of the RMS at go-live

4.2. OMS core functionality and services At initial launch of the OMS the list of organisations will contain a limited set of data, which will be expanded over time. The OMS data is available via the SPOR web user interface and programmatically via the API. Users will be able to search for organisations and locations and view details of organisations and locations. There are areas where the improvements are planned post go-live: •

change requests: submitting requests for new /updated organisations via OMS web interface (fully functional on the next release);

•

At go-live the new API for NCAs and industry to receive data from OMS is fully functioning. Submission of data via Change Requests (CRs) will be fully functional on the next release (expected in Q3);

•

export is expected to be fully functional on one of the next releases;

•

the general and technical documents are fully working as is the search, view and export. Imports can be done in XML in API, but for the CSV exports there are still some improvements to be made that will be introduced during post go-live releases.


Page 11/15

Figure 8. OMS core functionality and services

4.2.1. OMS data roll-out plan The OMS dictionary (list of organisations with associated physical locations) at go live will include NCA organisation data. The dictionary will gradually be expanded with new data. By the end of Q3 2017 EMA Data Stewards will have cleansed, standardised and published the following set of organisation data: •

Marketing Authorisation Holders (MAHs): Human (H) + Veterinary (V) Centrally Authorised Products (CAPs) and Human (H) Nationally Authorised Products (NAPs);

•

Marketing Authorisation Applicants (MAAs): (H+V) CAPs;

•

Maximum Residue Limit (MRL) applicants (Veterinary).

In December 2017 Sponsors (H) CAPs and NAPs will be included in the dictionary, around that time the project foresees the integration with electronic application form (eAF) and with xEVMPD (integration is subject to availability of resources at EMA and Member States. Further information will be provided via separate communication). Manufacturers (H+V) CAPs will be added by Q1 2018 and Manufacturers: (H+V) NAPs by Q3 2018. Additional Organisation data will be published in the future and the prioritisation of its inclusion in the dictionary will be defined at a later stage: •

Veterinary MAHs for NAPs;

•

Contract Research Organisations (CROs);

•

Clinical trials sites;

•

Academia;


Page 12/15

•

Hospitals;

•

Wholesale distributers;

•

MAA/MAH and manufacturers in the context of herbal and homeopathic medicinal products or compassionate use medicinal products;

•

QPPV (Qualified Person for Pharmacovigilance).

The figure below shows the current plan to expand the OMS dictionary content. Figure 9. OMS content release plan

5. RMS and OMS Service Level Agreement (SLA) RMS and OMS SLAs are indicative and set up based on experience. RMS requests aim to be validated within 2-5 working days and approved within 1-2 months (depending on the list). As for the OMS standard requests, these aim to be approved within 5 working days. In future the SLAs will be reviewed as these are new services where the workload still needs to be verified. For more information please consult Service Level Agreement (SLA) for the validation of change requests to update OMS and RMS content, document, which is published on the SPOR portal under the documents tab.


Page 13/15

6. Impacts at RMS and OMS go-live At RMS and OMS go-live, the 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, for example, changes in the Art.57 submission process are being discussed with Art.57 Implementation Working Group (IWG). Consultation is also taking place with Electronic Application Form (eAF) group to prioritise and plan for eAF integration with OMS (eAF is already integrated with EUTCT/RMS). From the go-live to RMS and OMS becoming mandatory in a given regulatory process there will be a period of time which will be not less than 6 months. In the meantime stakeholders (NCAs and industry) are asked to carry on with activities such as user registration (as per on-boarding plan), data mapping and submission of Change Requests (CR). See Figure 10. RMS and OMS stakeholder activities. Some activities such as submission of OMS Change Requests (CRs) are triggered by inclusion of the new OMS data in the dictionary and OMS functionality roll-out to stakeholders. More information will be provided to stakeholders to explain any applicable process changes and timings in due course. In the earlier section of this document it was highlighted that that RMS replaces EUTCT as the central repository and provider of Referentials. Therefore at go-live NCAs are asked to stop using EUTCT and start using the new RMS portal for Referentials. However, since the EUTCT also holds substance lists, it will remain available until EMA launches the Substance data Management Service (SMS). For that reason: •

EUTCT can still be used for browsing and downloading the Substance lists;

•

the process for requesting Substances does not change at go-live; −

•

users can continue sending emails to [email protected]

in October, 2017, [email protected] is scheduled to be replaced by the EMA Service Desk (Jira) tool. −

there will be a transitional period to move from the email process to the EMA Service Desk, and details will be communicated in due course.


Page 14/15

Figure 10. RMS and OMS stakeholder activities


Page 15/15