The workshop is being developed in close collaboration with thought-leaders from Health Authorities, industry, CROs, academia and patients representatives. Up to now discussions on risk management have been mainly theoretical and the practicalities of 'how to' has not been defined. Yet nobody is sure how much is actually 'enough' and how much is too little. Research Organisations are starting to create their approaches to risk assessment and risk-based monitoring and yet there are still questions which need to be addressed, especially on how to define, justify and "validate" of what is critical to patients' safety, integrity & rights, and data integrity. At the end of the workshop a discussion round with regulators is planned to give participants guidance whether the approaches developed during the workshop would be acceptable in their view.
This workshop will involve participants at one of two levels. Those that are more knowledgeable on risk assessment and management will drive during the workshop the discussion based on their 'hands on' experience, others that are less familiar with these concepts can adopt a more observational role.
More information are available here: www.luxclin.lu/Events/Details/?c=EVT5762KCV
Healthcare professionals who wish to be part of a unique network, providing access to up-to-date, accurate and validated information about clinical research.
Investigators and study staff who wish to be part of a unique network, in order to stay abreast of clinical trials taking place in Luxembourg and who are willing to further develop their competencies.