The 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.
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.
This essential two-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, including a clinical quality management framework.
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
Who Should Attend:
Anyone working on clinical trials including CRAs, monitors, clinical managers, project managers, lead clinical research associates, data managers, statisticians, study managers and those in QA/audit/QC and document management. It will also be relevant to those who work alongside the study team, such as regulatory affairs and pharmacovigilance.
Programme - Day One
Risk-based concepts and terminology
- Background and concepts to the risk management regulatory drive as applied to clinical trials
- Key risk management definitions and terminology
Outline of industry guidance and regulatory expectations
What are the key ICH, FDA, EMA, MHRA regulations/guidelines, including:
- ICH Q9, CH E6 R2, EU Clinical Trial Regulation and EMA good practice guide on risk minimisation and prevention of medication errors
Importance and benefits of risk management
- How is risk management applicable to clinical research, pharmacovigilance and regulatory affairs?
- Why is formal risk management important in EU, US and internationally?
- Benefits of using a risk management approach
Risk management process
- How to identify and evaluate risk
- How to control risk
- Communicating and reviewing risks
- How to report risk
New proposed ICH risk-based quality management system (QMS) for clinical trials
- What does this really mean and how does it look?
Clinical QMS framework
- What are the elements of a clinical QMS which include risk?
- What would a regulatory inspector expect to be in place for clinical trials?
Programme - Day two
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)
Risk-based approach to the protocol
- Quality by design (QbD) applied to the protocol
- How this is being applied to the design of protocols
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
- Centralised monitoring
- Quality tolerance levels
Case study example
- FDA latest question and answers guidance
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/r/qkdxwd