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 | 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...
