Entries by Ursula Tschorn

On-boarding of users to SPOR data services (updated document)

10. October 2018 in , /by

EMA Update Document 02 October 2018 version 2 EMA/307181/2017 Information Management Division On-boarding of users to SPOR data services  (document published (02 October 2018 version 2)) In a Nutshell: RMS and OMS data services were open to industry stakeholders in December 2017. Stakeholders were invited to start registering their SPOR users. As of today we […]

Masterdata Management for IDMP – How to keep SPOR OMS and Internal Systems in Sync?

10. October 2018 in /by

By Dieter Schlaps for IDMP1-News October 2018 Introduction to Masterdata Management IDMP SPOR OMS Sync The spectrum of possible IDMP solution architectures ranges from web-tool, “EVWeb”-type solutions where (a potentially huge amount of) data will have to be entered manually to large-scale integrated solutions which include “Master Data Management” components to extract, transform and load data […]

Organisation Management Services (OMS) Update (August 2018)

3. September 2018 in /by

Overview of OMS Change Request Process (updated) 16 August 2018 EMA/440168/2018 Information Management Division This document is intended to provide both guidance and information for stakeholders who are supporting the implementation of the SPOR programme and for all stakeholders who are using OMS data services. The information here applies to both human and veterinary stakeholders; however, there […]

Brexit Drug Supply

8. August 2018 in , /by

Brexit Drug Supply Brexit – is the after Brexit drug supply in Europe at risk? The German Federal Association of Pharmaceutical Manufacturers (BAH) sees the Brexit drug supply in Europe at risk, when Britain leaves the EU on the 29.3.2019. Neither the UK itself nor the EU, in the opinion of the BAH, are well […]

SMS, G-SRS, GINAS, EU-SRS Current Status July 2018

4. July 2018 in /by

SMS, G-SRS, GINAS, EU-SRS Current Status of the IDMP Substance Submodel Implementations in Europe and the US By Dieter Schlaps for IDMP1-News July 2018 The SMS, G-SRS, GINAS, EU-SRS Current Status as of July 2018 is beeing summarised in this blog article. FDA’s G-SRS System In FDA2‘s G-SRS1 system, the substance is registered per type, […]