Wainwright Associates; EMA; Pharmacovigilance; PV
EMA request feedback on the draft EU reference dates
April 19, 2012Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Wainwright Associates; EMA; Pharmacovigilance; PV
The European Medicines Agency has invited marketing-authorisation holders and other stakeholders to review and provide comments on the draft list …
Updated set of mandatory Article 57(2) requirements for marketing authorisation holders
March 15, 2012Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Wainwright Associates; EMA; Pharmacovigilance; PV
An updated set of mandatory requirements for Marketing Authorisation Holders (MAH) to comply with Article 57(2) of the forthcoming new …
Good Pharmacovigilance Practice modules released by European Medicine Agency
March 1, 2012Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Wainwright Associates; EMA; Pharmacovigilance; PV
The European Medicines Agency has now released drafts of the first seven Good Pharmacovigilance Practice (GPvP) Modules for public consultation. …
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