An Overview of Risk Management and Risk Analysis Techniques in Clinical Trials 2012

Key Topics

• Retrospective and prospective risk analysis techniques
• Common risk factors in clinical trials
• Risk analysis plan: identification, information gathering, decision, implementation and review
• Risk management: Key techniques in risk reduction, assessment, addressing, training and communication
• Expectations and responsibilities of the clinical project manager
• Overview of FDA requirements for risk management
• Challenges of large-scale and international clinical trials
• Role of various clinical team members: CRA, coordinators, sponsors and investigators

Who should Attend

Clinical research associates, Clinical Project Managers, Principal Investigators and sub investigators, Clinical coordinators, Regulatory Vice Presidents, Directors and Managers at sponsors, IRB personnel/li> and Attorneys – In-house or Outside Counsel.