ICH Q9 – Quality Risk Management has been present as an FDA Guidance
Document for almost 10 years, and this advocates the utilization of a risk assessment and then risk analysis methodology across all aspects of the pharmaceutical industry; which of course includes R&D and clinical trials. This risk management methodology achieves identification of risks, an analysis step and then deciding actions to be taken on the most significant. This process ensures that resources are not wasted on doing things that are not delivering benefit in mitigating significant risks.
This webinar will refresh basic Risk Management methodology and then establish how this fits in with the standard stages of a clinical trial. Regulatory inspectors will now expect to see evidence of a risk based approach to a clinical trial, and this course will address the topic of documentation to be created.
Areas to be Covered:
Risk management methodology
Utilize the basic principles to take a ‘risk-based approach’
Document risks identified
Prioritise risks and plan mitigation actions where necessary
Who will Benefit:
Data management Teams
Clinical Research Associates
Academic Research Organizations’ Staff
Representatives of any CROs or other contractors (ePRO etc) who will be supporting clinical trials
Researchers within a healthcare setting
And all clinical research professional embarking on a risk-based approach