EMA and MHRA Inspections: Successful Planning and Execution Tips and Techniques
Автор: Kathy Barnett
Загружено: 2020-01-23
Просмотров: 692
In recent years, the European Medicines Agency (EMA) and the UK’s
Medicines and Healthcare products Regulatory Agency (MHRA) have
increased the frequency and reach of their inspections. The outcome of the
inspection can determine whether a product will be granted a marketing
authorization in Europe or the UK, and good preparation will enable the
research to be shown in the most favorable light. This web seminar will help
learners to know how best to prepare their organizations for inspections by
the EMA and MHRA inspectorates, to know what the inspectors are looking
for, to understand what to expect during the inspection and to learn from real
inspection experiences.
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