Nov 30 2022, 1:00pm – 2:30pm
Virtual
Quality and risk management are focus areas within the now established International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6 (R2) Good Clinical Practice, the new version of ICH Q9 Quality Management and the new ICH E8R1 General Considerations in Clinical Studies and upcoming E6R3 revisions as part of the modernization of clinical trials.
This workshop covers the common nomenclature, principles of risk, simple risk models, grading and mitigation exercises, development, use of risk plans and risk log activities.
Learning objectives
In this session you will learn how to:
- Conduct basic risk identification and mitigation strategies
- Identify the site training requirements associated with implementation of risk management
- Understand the risk at the site or program level as part of study conduct
- Identify access points for readily available resources