Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
The highly-anticipated fifth edition is here! Get the must-have resource for achieving compliance with medical device regulations.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
The European Medicines Agency’s (EMA) management board on Monday endorsed the launch on 22 November 2017 of an improved system for collecting and monitoring suspected adverse events.
In the lead up to the launch of the new EudraVigilance system, EMA says national competent authorities, marketing authorization holders (MAHs) and sponsors of clinical trials have to make final preparations to ensure that their processes and IT infrastructures can work with the new system.
First launched in 2001, EudraVigilance is a database for reporting and evaluating suspected adverse drug events during the development, and following the marketing authorization of drugs in the European Economic Area (EEA).
In 2010, EMA’s management board adopted a EudraVigilance Access Policy, which came into force in July 2011 and outlined the data elements for and instructions on how to access Individual Case Safety Reports (ICSRs) from EudraVigilance for drug regulators, health professionals, patients and consumers, MAHs in the EEA and research organizations.
Among the benefits of the new system cited by EMA:
In preparation for the new system, EMA said it will support national competent authorities, MAHs and sponsors of clinical trials in the EEA through targeted e-learning and face-to-face trainings, webinars and information days. Users can trial the new functions of the EudraVigilance system and the internationally agreed format for ICSRs in a test environment as of 26 June 2017.
"The reporting of adverse reactions by patients and healthcare professionals to national competent auth
Further information is available on the EudraVigilance training and support webpage.
Announcement of the EMA Management Board Confirmation of full functionality of the EudraVigilance database
Green light given for new EudraVigilance system for collection and monitoring of suspected adverse reactions
Tags: EudraVigilance, ICSR, adverse events, marketing authorisation holders