This risk based clinical trial webinar will explain the importance of using risk management techniques in clinical research to comply with the latest focus on GCP inspection. It will show you how risk management can improve the quality of your clinical trials and demonstrate the importance of using risk analysis and risk management techniques in clinical trials.
Why Should You Attend:
FDA and EMA have communicated their expectations for trial oversight/monitoring, monitoring systems, and investigative site oversight. These are described in the FDA Guidance Oversight of Clinical Investigations: A Risk- Based Approach to Monitoring and the EMA Reflection Paper on risk-based quality management in clinical trials both of which will be reviewed in this web seminar.Areas Covered in the Webinar:
- Key risk based process/tools and techniques
- Review a risk based approach to protocol design
- Understand risk based approach to monitoring/data handling
- Best practice of these new risk requirements
Who Will Benefit:
- Clinical Development Managers and Personnel
- Clinical Research Archiving and Document Management Personnel
- Quality Assurance Managers and Auditors
- Consultants
- Regulatory Affairs Specialists
- Pharmacovigilance/Drug Safety
- Study Site Personnel
Speaker
Laura BrownCourse Provider
Laura Brown,
