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This takes into account the review of the comments received during the public consultation on the two GVP modules in 2016 including the draft reflection paper on the Collecting and Reporting Information on Off-Label Use in Highlights of the Updates to GVP Module IX Revision 1 Julie Durand EMA Discussants Fran ois Domergue EMA Nick Halsey EMA Sarah Vaughan MHRA and Anja van Haren MEB Gaby Danan PhV expert Fatima Sadurdine Hergy INFARMED END OF THE INFORMATION DAY Danan PhV Expert Rodrigo...
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What is eudravigilance information day?
Eudravigilance information day is an event organized by the European Medicines Agency (EMA) to raise awareness about the importance of reporting and monitoring the safety of medicines in the European Union.
Who is required to file eudravigilance information day?
Marketing authorization holders (MAHs) of medicinal products authorized in the European Economic Area (EEA) are required to file eudravigilance information day.
How to fill out eudravigilance information day?
Eudravigilance information day can be filled out electronically using the EudraVigilance system provided by the EMA.
What is the purpose of eudravigilance information day?
The purpose of eudravigilance information day is to monitor and analyze the safety of medicinal products in the EU in order to protect public health.
What information must be reported on eudravigilance information day?
Information on suspected adverse reactions, medication errors, and lack of efficacy related to medicinal products must be reported on eudravigilance information day.
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