Risk management is becoming increasingly important to running clinical trials and ensuring compliance with regulatory expectations. There are now numerous pharmaceutical guidelines covering risk management including ICH Q9 and the revised ICH GCP R2 guideline.
This essential one-day course will explain the importance of using risk management techniques in clinical research to comply with the latest focus on 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 and risk-based monitoring. You will learn how to identify, evaluate and implement specific risk-based techniques for risk management used in clinical trials.
This course will enable you to develop quality risk management principles applicable to clinical research, as well as to identify and share best practices for implementing risk management tools and approaches.
Benefits of attending:
- Understand risk management tools and when and how the tools are used in clinical research projects
- Learn how to plan risk-based approaches, how to document and where to focus to meet regulatory requirements and expectations
- Develop and apply risk management principles and tools to your clinical trials, including risk-based monitoring
- Identify and share best practices for implementing risk-based tools and principles
An overview of risk management
- Why risk management is important
- Definitions of key risk management terminology
- Brief overview of regulations and guidelines which cover risk management applied to clinical study-level risk management
Risk-based Quality Management System (QMS) - what does this really mean? How does it look?
- What are the elements of a QMS which include risk?
- What a regulatory inspector would expect to be in place for clinical trials
- Group discussion on using a clinical QMS, including risk
Risk-based processes/tools and techniques
- Examples of risk management processes
Risk-based tools including
- Root cause analysis
- Risk breakdown structure
- Risk log
- Failure modes and effects analysis (FEMEA)
- Risk matrix
- Examples of pharmaceutical risk tools for clinical trials including RACT (Risk Assessment Categorization Tool)
The risk-based approach to the protocol
- Quality by design (QbD) applied to the protocol
- How this is being applied to the design of protocols
The Risk-based approach to monitoring
- Different approaches to risk-based monitoring and examples of how this is carried out
- Discussion of what approaches and documents are used
- Case study example
The brief review of risk-based approaches to QC/QA (auditing)
- Example of best practice guide - RQA (Research Quality Association)
For more information about this conference visit https://www.researchandmarkets.com/research/vl4344/1day_course?w=4