Topics
- Regulatory responsibilities of the clinical project manager
- Overview of FDA requirements for clinical trials under an IND or IDE application
- Addressing adverse events and safety reporting
- An ideal clinical trial protocol and processes to amend it
- Managing investigational products: stability, storage, accountability, and expiry
- Management of randomization, blinding, unblinding, and DSMB review
- Recruitment strategies
- IRB review and review of the IRB processes by sponsors
- When and how to seek regulatory clarification
- What and what documents not to submit to FDA
- Corrective and Preventive Actions (CAPA) for clinical trial projects
- Risk management: Key techniques in risk reduction, assessment, addressing, training and communication
- Challenges of large-scale and international clinical trials
- Do`s and don`ts of investigator meetings
Who should Attend
Clinical research associates, Clinical Project Managers, Principal Investigators and sub investigators, Clinical coordinators, Regulatory Vice Presidents, Directors and Managers, IRB personnel and Attorneys – In-house or Outside Counsel.
