A comprehensive package of PV Services 

 
 
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Risk Management

The concept of Risk Management was first standardized in the ICH E2E document in 2004 which defines Pharmacovigilance Planning accepted in all 3 ICH regions. In 2006 the European Union introduced Risk Management Plans (RMP) and it was updated with the introduction of the Good Pharmacovigilance Practice legislation in 2010/2012 and latest in 2017
 

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Safety System Implementation

Implementation of a compliant Safety Systems require expertise in both Drug Safety, Technology and Validation. We can support you throughout the process