by Ursula Tschorn | Oct 10, 2018 | News
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...
by Ursula Tschorn | Sep 3, 2018 | News
Text Mining for IDMP – Kill or Cure? By Dieter Schlaps for IDMP1-News September 2018 Brief View into the History of Text Mining The use of Text Mining for IDMP is based on historic experience. Artificial Intelligence methods to aid decision making in Medicine...
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 | 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...
by Ursula Tschorn | Nov 6, 2016 | Allgemein, News
Dosing IDMP1 Joint Venture The Dosing IDMP1 Joint Venture is building the Bridge from IDMP to E-Health. The supply of medicines to the population is a particular challenge worldwide: there are countless medicines and active ingredients that can develop unpredictable...
by Ursula Tschorn | May 27, 2016 | News
ISO Focus ISO Focus is the official magazin of the ISO Organisation. Published in English, French and Spanish six times per year, ISOfocus is the gateway to International Standards. Whether a multinational enterprise faced with major decisions or a small business...
by Ursula Tschorn | May 27, 2016 | Allgemein, News
EMA has published the recommendation for 79 data elements to be implemented for the IDMP Iteration 1. This recommendation can be found in the document at page 16: Download document...
by Ursula Tschorn | Jun 14, 2015 | EMA
EMA´s landingpage IDMP on implementation of International Organization for Standardization (ISO) identification of medicinal products (IDMP) standards has been launched. There are described the common standards, formats and terminologies which should be used in...
by Ursula Tschorn | Feb 8, 2015 | EMA
The European Medicines Agency (EMA) has published a guide to support the implementation of a new international standard for the safety monitoring of medicines in the European Union (EU). The so-called ISO ICSR standard improves the reporting of suspected side effects...
