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Pharmacovigilance deep dive: risk minimisation measures

European Pharmaceutical Review

The sampling strategy must be supported by sound and properly cited sources whose conclusions must be presented as supportive elements in the study documents. The following four elements of sampling methodology were found to be under-documented in RMM effectiveness studies: Supporting documentation for country/region selection.

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Why Are FDA Inspections So Ineffective and Disappointing?

The People's Pharmacy

There have been problems with records in the past: deceit, falsification of documents and even outright fraud. Since the start of 2013, pharmaceutical companies based in the U.S. The Chinese company, Zhejiang HuaHai Pharmaceutical company in Linhai, China, had changed its manufacturing process.

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