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Dieter Schlaps, ITCLS

Text Mining for IDMP – Kill or Cure?

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Clinical Trials Portal

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EMA launched Referentials Management Service (RMS)

EMA launched Referentials Management Service

The European Medicines Agency (EMA) has launched the Referentials management service (RMS) and Organisations management service (OMS) to support EU-wide regulatory activities.

The RMS and OMS manage two of the four domains of substance, product, organisation and referential (SPOR) master data in pharmaceutical regulatory processes. They lay the data foundations for delivering the substance and product data management services.

The SPOR services support the implementation of ISO IDMP standards in the European Union (EU).

Users can access information to these data services directly online via the SPOR portal.

User registration

EMA will invite national competent authorities 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 the RMS from June 2017;

Industry:

Update: EMA will invite industry stakeholders to begin registering their ‘super users’ from 15 December 2017 and other users from January 2018.

For more information see the Referentials Management Service (RMS) and Organisations Management Services (OMS) user on-boarding plan.

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EMA Update IDMP SPOR September 2017

EMA Update on IDMP SPOR September 2017

4 September 2017, EMA/580454/2017, Information management division

The EMA update IDMP SPOR September 2017 envisaged additional post implementation releases of RMS and OMS data services to enhance functionality (please see the plan below). The first improvements to these data services were released on 10 August 2017 (release notes are available from the SPOR portal). Two more releases of RMS and OMS are planned for 2017:

  • RMS & OMS version 2.2, planned for 16 October 2017;
  • RMS & OMS version 2.3, planned for 17 November 2017.

Prior to the version 2.2 the EMA will run another round of OMS user acceptance testing (UAT), commencing 15 September 2017. The scope of this round of the OMS UAT will cover functional areas not tested, or which were unsuccessful, in the previous UAT held in March/April 2017.

news_ema_spor_sept_2017

Participation in this UAT is open only to those testers who participated in the previous round of UAT, plus those Industry Vendors who submitted a request during the recent Call for Expressions of Interest (closed Thursday 31 August).
The results of this round of UAT should be issued formally before the end of October 2017. Defects reported are expected to be fixed and included in version 2.3, due for release in November 2017.
A slide deck from the OMS UAT preparatory webinar held on 1 September 2017 can be accessed here (choose documents / view).

Following the October 2017 release (version 2.2), EMA will invite industry stakeholders to begin registering their Super Users and Users. Precise date will be communicated during October.

 

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EMA Updated Timeline for the IDMP SPOR API User Access Test Go-Live

EMA Updated Timelines for the SPOR API

The start of the SPOR API user access tests has been postponed.

SPOR API

Referential Management System (RMS) and Organisation Management System (OMS) User Acess Test (UAT)/go-live. The originally for Q4 2016 planned UAT /go-live will be postponed.

SPOR API Documentation

The first edition of the SPOR API documentation version 1.6 (API schemas, OMS & RMS message formats and HL7) is accessible for interested parties for a free download in the SPOR Wiki in this website.

This version of the API specification covers both RMS and OMS. This has been taken through consultation during April to July 2016 and the feedback has been incorporated in the specification (consultation is now closed).

Please note that in the SPOR API specification, the services are set out in Section 6 and those that are OMS-specific are marked “O”, RMS-specific are marked “R”, and services shared by both RMS and OMS are marked as  “RO”.

The documents have been shared with the SPOR Task Force and UAT testers. They will be published alongside the reference material on the public website and on Confluence.

Reference materials

EMA is currently finalising a number of key documents as reference materials on SPOR. These will provide more detailed information on topics such as RMS operating model, OMS operating model, high level changes and an introduction to ISO IDMP.

EMA is planning to publish the first set of reference materials in the coming weeks on the EMA external website. A selection of these documents has been reviewed by NCA and Industry Change Liaisons and their suggestions have been incorporated.

Feedback

To ask questions and provide feedback or suggestions for additional topics you would like to hear more about, please email the team at: SPOR-Change-Liaisons@ema.europa.eu