Entries by Ursula Tschorn

Decision on EMA Relocation has been published

Decision on EMA relocation has been published The EMA is currently based in London’s Docklands business district but must move when Britain leaves the bloc in March 2019. EU agencies are not allowed to be based outside the union. The fight for one of the most prised spoils of Brexit has come to a climax […]

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 […]

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 […]

How FDA intends to introduce IDMP through the backdoor

How will FDA introduce IDMP? FDA proposes structured data for the CMC Module 3 of the eCTD standard (Blog content by our partner Dieter Schlaps) A few days ago, FDA has circulated a remarkable document for commenting, entitled “Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Elements and Terminologies”[1]. The document is the result of a […]

EMA Updated Timeline IDMP SPOR (June 2017)

Download EMA Updated Timeline IDMP SPOR June 2017 EMA Updated Timeline IDMP SPOR June 2017. EMA´s IDMP programm envisages the release of ISO IDMP compliant (11239 & 11240) Referential Management Services (RMS) and Organisation Management Services (OMS) on 19th June 2017 (subject to confirmation). The scope of the release includes data content, functional capabilities and […]