This workshop aims to provide basic knowledge of the elements in Risk Based Monitoring (RBM). Keeping up with recent
amendment to ICH-GCP (ICH-E6-R2) guidelines, you will be able to understand the new requirements as well as how risk
based approaches to monitoring helps your study or organization to improve quality and safety.
Who is the course for?
The course is aimed at clinical operations team members, especially study managers and operational managers, who wish to obtain a general understanding of how to implement RBM. The course will also serve as a good orientation for CRAs and scientific team members of Pharma organizations who are assessing the benefits of utilising RBM.
Good experience in the clinical monitoring or study management domain.
– Current state of clinical research operations
– Essentials of ICH-E6(R2) and regulatory outlook as related to RBM
– Hands-on application of RBM combining an explanation of the key concepts and practical application:
- Risk planning process
- Developing an Integrated Quality Risk Management Plan (IQRMP)
- Creating Risk Indicators for a study
- Identifying the correct Key Risk Indicators (KRIs) and Key Performance Indicators (KPIs) for your needs
- Simplifying large data into insights using data analytics and visualizations
– A detailed overview of how next generation monitoring will look :
- Central monitoring model
- Performing central monitoring – How to do it – Process & people aspects
- Integration between central and site monitoring teams
– Conclusion & wrap up
What will we do in the workshop?
This workshop will introduce the key concepts behind RBM and how to apply them in the real world to provide tangible benefits. Hands-on experience of simulating risk planning and monitoring will be provided.
Type of training
At the end of the training
The workshop not only provides orientation to RBM but also prepares the audience to implement it at a study, program or
organizational level. It will also help the audience understand basic data and technology requirements when they implement
RBM and comprehend how central monitoring is performed and integrated with the traditional monitoring approach for
Abby Abraham is a co-founder of Algorics and serves as Vice President, Clinical Solutions.
Abby as over 17 years of experience in clinical research. He has significant expertise in clinical trial monitoring, study management and operational management and worked in senior roles with global CROs in the past. At Algorics, he devises tailored solutions to implement risk based monitoring and optimize operations by applying data-driven methodologies and novel technologies. He provides global thought leadership in RBM and has published white papers, case studies and several papers in scientific journals. He has also chaired and presented in several global forums in recent years.