Regulatory Perspectives of Clinical Project Management: Meeting FDA Requirements for Clinical Trials 2015

Key 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.