Risk management is becoming increasingly important to running clinical trials. There are now numerous pharmaceutical guidelines covering risk management including ICH Q9, the revised ICH GCP R2 guideline, the revised EU Clinical Trial Regulation guideline on risk management and several other risk management clinical research standards and initiatives.
This essential one day course 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. You will learn how to identify, evaluate and also how to implement specific risk-based techniques for risk management used in clinical trials.
Anyone working on clinical trials including CRAs, monitors, clinical managers, project managers, lead clinical research associates, data managers and statisticians, study managers, quality assurance/audit and QC, document management. It will also be relevant to those who work alongside the study team, such as regulatory affairs.
An overview of risk management
Risk-based Quality Management System (QMS) – what does this really mean? How does it look?
Risk-based process/tools and techniques
Risk-based approach to the protocol
Risk-based approach to monitoring/data handling
Brief review of risk-based approaches to QC/QA (Auditing)
Laura Brown (28 Mar 2019)
Dr Laura Brown MBA, BSc,PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. She has more than 20 years’ experience of quality assurance in the pharmaceutical industry and has worked for several companies, including GSKs Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality assurance including risked based approaches to quality systems, data Integrity and project management in the pharmaceutical industry. She regularly writes on pharmaceutical regulatory issues including “The Planning of International Drug Development”, in the Clinical Research Manual, Euromed and the “Impact of Brexit”, RQA Journal 2017.
This course qualifies for the following CPD programmes: