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SUSAR Reporting

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  • Ekkehard Herpers
    18/09/2006 11:09
    An internationally operating company based in Germany has a MA for product A in some EU countries. Multinational clinical trials are performed for this product in some EEA countries. How are SUSARs to be reported from spontaneous reports (not originiating from clinical trials)?
  • Dominique Chesnais
    10/10/2006 11:29
    Please refer to Volume 9 - Pharmocovigilance that can be downloaded from http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev9.htm for managing suspected unexpected serious adverse reactions. Information about Volume 10 - Clinical Trials is at http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev10.htm Suspected unexpected serious suspected adverse reactions are discussed in both links.
  • Mian
    23/06/2019 22:51
    Please Please answer this 2 minute Survey for my Thesis it only take 2 3 minutes of your precious time i really appreciate your help in this regard Please also pass it to your Fiends, Colleagues and workers Thanks in Advance https://www.surveymonkey.com/r/QV6TNPJ
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