by Ursula Tschorn | Mar 23, 2018 | Abbreviations, IDMP Solutions, ISO IDMP Standards
SPOR (as of 23.03.2018, Ursula Tschorn, IDMP SPOR Industry Change Liaison) SPOR is short for Substances Products Organisations and Referentials in the IDMP projects of the EMA. SPOR data services will act as the vehicle for implementation of ISO IDMP standards in the...
by Ursula Tschorn | Jan 28, 2018 | EMA, News
What is a Clinical Trial? A Clinical Trial is a study performed to investigate the safety or efficacy of a medicine. For human medicines, these studies are carried out in human volunteers. The Clinical Trial Portal and IDMP SPORS EMA’s new Clinical Trials Portal...
by Ursula Tschorn | Jan 28, 2018 | EMA, News
Note: Meet IDMP1 Partner Dieter Schlaps at the RSIDM in North Bethesda Feburary 5-7, 2018 IDMP1 will be present at the upcoming Regulatory Submissions, Information and Document Management Form (RSIDM), at North Bethesda (US), from February 5-7, 2018. If you are there,...
by Ursula Tschorn | Nov 20, 2017 | Uncategorized
eAF is short for Electronic Application Form. Since 1 January 2016 the eAF is mandatory to use for all new Marketing Authorisation Applications, Renewals and Variations within all procedures in Europe.
by Ursula Tschorn | Sep 13, 2017 | FDA, News
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...
