Ensure your clinical trials comply with the latest focus on GCP inspections and develop your own quality risk management principles and procedures
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 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.
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.
Benefits of attending:
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.
Dr Laura Brown MBA, BSc (Biochemistry), BSc (Psychology), PhD, Diploma in Clinical Science, FICR, is a Pharmaceutical Management and Training Consultant, Course Director for the MSc in Clinical Research at the University of Cardiff, and MSc Regulatory Affairs, TOPRA. She has more than 19 years’ experience in the pharmaceutical industry and has worked for several companies, including GlaxoWellcome, Hoechst Marion Roussel, Farmitalia and Phoenix International. She has worked in Drug Development, Clinical Research, Quality Assurance and Marketing and has a particular expertise in Clinical Research and GCP issues. She was Chairman of the ACRPI GCP Forum for six years. She regularly writes on clinical research issues and ICH GCP, is author of SCRIP’s GCP guide and is a member of the editorial board of the Good Clinical Practice Journal. She is co-author of several books on management including ‘Developing the Individual’, 'The Ultimate Book of Business Skills’ and ‘Pharmaceutical Project Management’.
We don't have any currently scheduled dates for this course but we can customise it to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
See below or contact us to discuss yor requirements.
Very interesting training, excellent for a clear and well structured introduction to Risk Management in Clinical Research.
Mar 28 2019
Clinical Assessment Manager, JT International
Feb 26 2018
All excellent - thank you!
Group Quality & Training Director, ADAMAS Consulting