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.
Why should you Attend:
This essential webseminar will explain the importance of using risk management techniques in clinical research to comply with the latest focus on GCP inspection in this area. 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.
Areas Covered in the Session:
Have explained key risk based process/tools and techniques
Review a risk based approach to protocol design
Understand risk based approach to monitoring/data handling
Hear 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
Regulatory Affairs Specialists
Pharmacovigilance /Drug Safety
Study Site Personnel
Dr. Laura Brown , PhD, MBA, Diploma Clinical Sciences, is an independent QA and training consultant in the pharmaceutical industry. She is a managing director with LB Training and Development Ltd., course director for the M.Sc. in Clinical Research, School of Pharmacy at the University of Cardiff, and course director for M.Sc. Regulatory Affairs, TOPRA.
Event Fee: One Dial-in One Attendee Price: US$150.00