Clinical Trial Audits in Practice 2016

The Clinical Trial Audits in Practice 2016 is dedicated to any professional involved in the monitoring and/or QA of clinical trials.

Topics

• Quality management, defining quality
• Regulatory framework EU and ICH
• Trial system and vendor audit in practice
• Risk-based approach to audit and inspection planning and conduct
• Communication of audit findings
• System audits
• Inspections by European and other authorities