by Ursula Tschorn | Aug 1, 2018 | ICSR, Pharmacovigilance
The WHO Programme (World Health Organization) is a specialized agency of the United Nations. The goal of this organization is to “achieve better health for all through prevention and control of diseases.” One way they do this is by tracking adverse events...
by Ursula Tschorn | Jul 30, 2018 | E-Subscription
Periodic Adverse Drug Experience Report PADER Post-approval cumulative reports of safety include Periodic Adverse Drug Experience Reports (PADERs) in the U.S. and Periodic Safety Update Reports (PSUR) in many other regions, including in Europe. Their purpose is to...
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,...