Umgang mit Anforderungen der elektronischen Einreichung von Arzneimitteln beim pharmazeutischen UnternehmerDargestellt am Beispiel von Änderungsanzeigen Dipl.-Biol. Andrea Schmitt Pfizer GmbH Deutschland, Karlsruhe How to Deal with the Requirements of the Electronic Submission of Drug Applications by Pharmaceutical Companies / Illustrated by variations The proceeding development of modern information technology induces the desire to take advantage of its potential in the cooperation with regulatory authorities. Nonetheless, the introduction of the electronic submission of regulatory documents needs to be prepared carefully, requiring intense planning activities by regulatory authorities as well as pharmaceutical entrepreneurs and a detailed framework. The complexity manifests itself especially clearly when a routine task like a variation is considered step by step. Key words AMG-EV · Änderungsanzeigen · Elektronisches Dokumentenmanagement-System (eDMS) eSubmission · |
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pharmind 2003, Nr. 05a, Seite 525
