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Risikomanagement in der Arzneimittelsicherheit. Ansätze zur Effektivitätsbewertung von Risikominimierungsmaßnahmen in den USA und Europa im Vergleich

Risikomanagement in der Arzneimittelsicherheit. Ansätze zur Effektivitätsbewertung von Risikominimierungsmaßnahmen in den USA und Europa im Vergleich

          
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About the Book

Ein wesentlicher Bestandteil des Risiko-Managements in der Pharmakovigilanz besteht darin, identifizierte Risiken zu minimieren. Welches Risikominimierungsinstrument im konkreten Fall nützlich und sinnvoll ist, hängt von verschiedenen Faktoren ab - wie dem Indikationsgebiet, der Art des Risikos und der Patientenpopulation. Der Erfolg der jeweils ergriffenen Risikominimierungsmaßnahmen kann jedoch vorab nicht garantiert werden. Daher ist eine Effektivitätsbewertung von Risikominimierungsmaßnahmen unabdingbar. Kerstin Bendig entwickelt in ihrer vorliegenden Studie Ansätze zur Effektivitätsbewertung von Risikominimierungsmaßnahmen. Als Basis dafür dienen ihr die regulatorischen Vorgaben zur Risikominimierung in den USA und Europa. Die Autorin analysiert ausgewählte Beispiele von veröffentlichten Risikominimierungs- und -linderungsstrategien (Risk Evaluation and Mitigation Strategies, REMS) sowie das in diesen aufgeführte Vorgehen zur Effektivitätsbewertung. Darüber hinaus prüft sie die Strategien auf ihre Allgemeingültigkeit und Übertragbarkeit auf andere Fälle. In Verbindung mit einer Nutzungsanalyse verfügbarer Quellen für Daten zur Effektivitätsbewertung leitet Kerstin Bendig Ansätze ab, die Hinweise für die Planung und Durchführung einer Effektivitätsbewertung von Risikominimierungsmaßnahmen geben. Die vorliegende Studie gibt dem Leser Einblick in eine mögliche Vorgehensweise für den strukturierten Ablauf einer solchen Effektivitätsbewertung. Sie zeigt aber auch Möglichkeiten und Grenzen dieser Bewertungsvorgänge auf. Die Verknüpfung von regulatorischen Vorgaben mit Beispielen aus der Praxis macht die Herausforderungen deutlich, die es mit sich bringt, diese Prozesse in das Tätigkeitsfeld der Risikominimierung zu integrieren und konsistent umzusetzen.


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Product Details
  • ISBN-13: 9783838204383
  • Publisher: Ibidem Press
  • Publisher Imprint: Ibidem Press
  • Height: 210 mm
  • No of Pages: 110
  • Spine Width: 6 mm
  • Width: 148 mm
  • ISBN-10: 3838204387
  • Publisher Date: 01 Nov 2012
  • Binding: Paperback
  • Language: German
  • Returnable: N
  • Weight: 140 gr


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Risikomanagement in der Arzneimittelsicherheit. Ansätze zur Effektivitätsbewertung von Risikominimierungsmaßnahmen in den USA und Europa im Vergleich
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