Ensure your clinical trials comply with the latest focus on GCP inspections and develop your own quality risk management principles and procedures
24 Sep 2018
& 28 Mar 2019
GBP 699 599 *
EUR 979 839 *
USD 1,090 934 *
* When you book before 15 Aug
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)
Dr Laura Brown MBA, BSc (Biochemistry), BSc (Psychology), 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 GlaxoWellcome, Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality systems including document management and Data Integrity. She was Chairman of the ACRPI GCP Forum for six years. She regularly writes on pharmaceutical regulatory issues.
This course qualifies for the following CPD programmes: