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PharmacoVigilance Day, XI Edition

12 aprile 2018 - Milano

EudraVigilance MAH experience, data quality, signal management and audits

 


Key Speaker Dr. Calin Lungu – EudraVigilance and XEVMPD Trainer for the EMA - CEO of DDCS

 

Since 22 November 2017, a lot has changed in the area of pharmacovigilance reporting and signal detection. Emphasis is placed on MAHs to use the new tools made available by the EMA for reporting (EVWEB) and for signal management (EVDAS). New software has been made available and data quality is a must. Inspectors and auditors can prepare inspections and audits using the available EudraVigilance functionalities and tools.

EudraVigilance – news and system status

EVDAS – available reports and MAH experience

EudraVigilance Data Quality 

Pharmacovigilance audits

The conference is aimed to Users of EudraVigilance and to all professionals involved in the Signal detection as well as to pharmacovigilance inspectors and auditors.

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