Compliance for Risk Based Approaches for Clinical Trials 2018

Topics

• The regulations and guidelines which cover risk management applied to clinical study - level risk management
• The new requirements for risk management in clinical trials
• Have explained key 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
• A risk based approach to protocol design
• Best practice of these new risk requirements

Who should Attend

• Monitors
• Clinical Research Associates (CRAs)
• Project Managers
• Clinical Managers
• Data Managers and Statisticians
• Lead Clinical Research Associates
• Clinical Development Managers and Personnel
• Study Managers, Document Management
• Quality Assurance Managers and Auditors
• Clinical Research Archiving and Document Management Personnel
• Regulatory Affairs Specialists
• Consultants
• Study Site Personnel
• Pharmacovigilance /Drug Safety