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New QP requirements 'in sync with real world', but EU drug industry concerns persist

This article was originally published in SRA

Executive Summary

Pharmaceutical companies have largely welcomed the European Commission's revised draft guideline on qualified person (QP) requirements as the update aims to bring the document in line with the current globalized nature of the drug industry1,2. They are, however, worried about the practical implementation of some of the provisions in the proposed guideline, saying these could lead to unnecessary challenges "while feasible alternatives are at hand".

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