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European Union pharmacovigilance capabilities: potential for the new legislation

John Joseph Borg1, Amy Tanti2, Dimitrios Kouvelas3

  • 1Medicines Authority, 203 Level 3, Rue D'Argens, Gzira, GZR 1368, Malta.

Therapeutic Advances in Drug Safety
|August 25, 2015
PubMed

Keywords:
Pharmacovigilance and Risk Assessment Committeeadverse drug reactionsdrug safetyperiodic safety update reportspharmacovigilancepost authorization safety studiesregulatory affairssignal detection

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