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Arzneimittelfälschungen und die neuen Regularien. Eine Handlungsempfehlung

Arzneimittelfälschungen und die neuen Regularien. Eine Handlungsempfehlung

          
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About the Book

Plagiatoren machen schon lange nicht mehr bei gefälschten Markenartikeln wie Kleidung, Uhren und Handtaschen halt. Längst haben sie erkannt, wie lukrativ die Fälschung von Arzneimitteln sein kann. Durch organisiertes Verbrechen haben wirkungslose oder gar toxische Arzneimittelfälschungen bereits Todesopfer gefordert. Dabei finden sich Fälschungen nicht nur in fernöstlichen Ländern, sondern haben längst selbst streng regulierte westliche Länder erreicht. Die EU-Fälschungssicherheitsrichtlinie 2011/62/EU soll diesen Herausforderungen begegnen. Bis 2017 müssen sämtliche Pharmaunternehmen verschiedene Sicherungsmaßnahmen implementiert haben, um Arzneimittelfälschungen erfolgreich vermeiden und identifizieren zu können. Esther Destratis beschäftigt sich umfassend mit der Thematik und weist auf verschiedene Möglichkeiten für sichtbare, unsichtbare und digitale Sicherungsmaßnahmen an Arzneimitteln hin. Außerdem zeigt sie auf, wie diese anhand des Demingschen PDCA-Zyklus erfolgreich umgesetzt werden können. Dieses Buch trägt erstmals alle wichtigen Fakten zum Thema Arzneimittelfälschungen zusammen: Was sind Arzneimittelfälschungen überhaupt? Welche Gefahren gibt es? Wie reagiert die europäische Gesetzgebung darauf? Was können Pharmahersteller tun, um gesetzeskonform zu handeln und ihre Patienten vor Plagiaten zu schützen? Mit welchen Instrumenten können pharmazeutische Unternehmen die geforderten Sicherungsmaßnahmen erfolgreich in ihr Qualitätsmanagementsystem einbauen? Destratis' Studie wendet sich an alle an der pharmazeutischen Lieferkette Beteiligten, insbesondere an diejenigen, die die spannende Aufgabe haben, die geforderten Maßnahmen in ihrem Unternehmen umzusetzen.


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Product Details
  • ISBN-13: 9783838207711
  • Publisher: Ibidem Press
  • Publisher Imprint: Ibidem Press
  • Height: 210 mm
  • No of Pages: 104
  • Spine Width: 6 mm
  • Width: 148 mm
  • ISBN-10: 3838207718
  • Publisher Date: 01 Apr 2015
  • Binding: Paperback
  • Language: German
  • Returnable: N
  • Weight: 136 gr


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Arzneimittelfälschungen und die neuen Regularien. Eine Handlungsempfehlung
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