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.
- Describe how to be inspection ready at all times
- Explain the differences between EMA and MHRA inspections, and their significance
- Identify tools to prepare the organization to perform at its best during the inspection
- Describe how to mitigate inspection findings
- Identify which records should be made available for the inspection
- Clinical Operations Staff
- Facilitators of the inspection
- Senior Management Personnel who have a role in the inspection
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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.