Clinical Research Training for Senior CRAs 2014

Topics

• Refreshing and update of the current European legislation of clinical research
• Importance of international research – the role of the ICH process
• The informed consent: verification of the process
• Monitoring plan development
• Upgrading monitoring tasks: prioritizing tasks, better monitoring reporting, efficient tracking, dealing with non-compliances
• Improving recruitment of investigators and of study subjects
• Expedited safety reporting
• Quality systems and audits

Who should Attend

• Experienced people working in clinical data processing
• Clinical Research Associates (CRAs) with min 2 years of experience
• Regulatory affairs
• Biostatistics