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.
