Ensure your clinical trials comply with the latest focus on GCP inspections and develop your own quality risk management principles and procedures
Why you should attend?
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.
Continuing professional development
This course qualifies for the following CPD programmes:
- CPD certificate of attendance
An overview of risk management
- Why risk management is important?
- Definitions of key risk management terminology
- Regulations and guidelines which cover risk management applied to clinical study-level risk management
Risk-based QM system – what does this really mean? How does it look?
- What are the elements of QM system and what a regulatory inspector would expect to be in place for clinical trials
- Group discussion – participants share what systems they have in place
Risk-based process/tools and techniques
- Examples of risk management process
- Risk-based tools including
- Root cause analysis – 5 Whys
- Risk register
- 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/data handling
- Different approaches to risk-based monitoring and examples of how this is carried out – eg of a risk-based monitoring plan
- Discussion of what approaches and documents are used
- Case study example
Brief review of risk-based approaches to QC/QA (Auditing)
- Example of best practice guide RQA (Research Quality Association)
Dr Dr. Laura Brown,
Pharmaceutical Management and Training Consultant ,
University of Cardiff
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. Laura 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 Board of the Good Clinical Practice Journal. In addition to her scientific qualifications, she has a degree in psychology and an MBA.
Laura is co-author of several books on management including Developing the Individual, The Ultimate Book of Business Skills and Pharmaceutical Project Management.
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.
11 Thurloe Pl,
The Rembrandt Hotel is located at 11 Thurloe Place, London, SW7 2RS. The hotel’s location in central London couldn’t be better, whether you’re travelling for business or leisure. You’ll be right between two of London’s most fashionable areas – South Kensington and Knightsbridge – within walking distance of museums, theatres, Harrods and Hyde Park.
You can hop on the Tube at South Kensington and take the District, Circle or Piccadilly lines direct to the City of London, Heathrow Airport and all other areas of the city. Look out of your window and you may well see the Victoria and Albert Museum – it’s right across the street.