Transcription of Guideline on good pharmacovigilance practices (GVP)
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Guideline on good pharmacovigilance practices (GVP)
See websites for contact details European Medicines Agency Heads of Medicines Agencies The European Medicines Agency is an agency of the European Union European Medicines Agency and Heads of Medicines Agencies, 2015. Reproduction is authorised provided the source is acknowledged. 3 August 2015 EMA/228028/2012 Rev 1* Guideline on good pharmacovigilance practices (GVP) Module IV pharmacovigilance audits (Rev 1) Draft finalised by the Agency in collaboration with Member States and submitted to ERMS FG 12 July 2012 Draft agreed by ERMS FG 20 July 2012 Draft adopted by Executive Director 25 July 2012 Start of public consultation 26 July 2012 End of consultation (deadline for comments)
Internal Control: Internal control is an integral process that is effected by an entity’s management and personnel and is designed to address risk and provide reasonable assurance that in pursuit of the entity’s mission, the following general objectives are …
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