概要
For many organisations, clinical trial regulatory inspections are obligatory for achieving or maintaining market authorisation. However, it can be challenging for your organisation to sustain the required level of preparedness while simultaneously dealing with data integrity, data privacy and Good Clinical Practice (GCP).
This course teaches you oversight strategies for ensuring that you can sustain your inspection readiness throughout the clinical trial development process. Using practical examples, we will provide insights into helping your organisation prepare for an inspection in this digital era. We will also show you those areas of quality, data integrity and process improvement where you should focus your attention if you are to be ready to meet specific EMA, FDA and MHRA requirements.
