Risk Management in Clinical Trials 2018

Topics

• Regulations and guidelines which cover risk management applied to clinical study-level risk management
• New requirements for risk management in clinical trials
• Key risk based process/tools and techniques
• The elements of QM system are and what a regulatory inspector would expect to be in place for clinical trials
• Risk based approach to monitoring / data handling
• Risk based approach to protocol design
• Best practice of these new risk requirements
• Risk based approaches to QC / QA (Auditing)

Who should Attend

• Clinical Research Associates
• Clinical Development Managers and Personnel
• Quality Assurance Managers and Auditors
• Clinical Research Archiving and Document Management Personnel
• Consultants
• Clinical Development Managers and Personnel
• Pharmacovigilance /Drug Safety
• Regulatory Affairs Specialists
• Study Site Personnel