Text Mining for IDMP – Kill or Cure?
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...
Clinical Trials Portal
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...
Application Form (eAF) as a Vehicle for IDMP Data Submissions
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,...
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...