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With more than 16 years within GCP, clinical research and device-/pharmacovigilance, I have an extensive knowledge and experience in several clinical trials processes/activities such as GCP training, GCP audit/inspection, Quality Management System, SOP writing, process expert in protocol preparation, informed consent, monitoring, IMP labelling/packaging, IV/WRS set-up and safety data handling. I always focus on high quality and compliance, as quality and compliance are crucial foundation for patient safety and successful results.