Training

	Practically oriented training and seminars developed to meet the individual needs of your company and your employees.
	Legal basics and requirements Medicinal Products Act (AMG), The Act on Medical Devices (MPG), ICH-GCP guidelines, EU regulations, ethics committees, competent authority procedures, … Tasks, responsibilities, work organization Pre study-, initiation-, monitoring and close-down visits, responsibilities, essential documents, GCP/Good Clininal Practice, … Monitoring Site selection and preparation, source documentation, data management, case report forms (CRF), investigational product handling, contact and communication with the site/investigator, … Internal and external documentation obligation for clinical trials Trial Master File/Investigator Site File, insurances, notification of beginning and end of a clinical trial, AE/SAE reporting, common gaps in documentation, laboratory, checklists, archiving, … Quality management SOPs, audits and inspections Biostatistics and data management Reading and understanding of publications, “statistics easy to understand” without complicated formulas
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