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.
To decide which Group you should be working in we would like you to ask yourselves the following questions but do bear in mind there is no wrong answer, these questions are for you to consider your personal level of knowledge and to see where you best fit into these interactive workshops.
1. Yes, I am currently applying QbD methods (including Risk-Based Monitoring) to clinical trials.
2. Yes, I am starting to apply/piloting QbD methods (including Risk-Based Monitoring) to clinical trials.
3. No, I am starting to establish the infrastructure for future clinical trials.
4. No, I am not currently applying any QbD methods.
If you have answered 'Yes' to either questions 1 or 2 then you would be a suitable candidate to take part in the active workshop, Group A, if you wish. Group A people can join Group B, but if you answered 'No' to questions 3 or 4 then you will be more suitable for Group B. The role of Group B will be more of a listening role, with the possibility of asking questions but not actually demonstrating QbD principles with the Workshop Leaders in the workshops. Group A will be completing tasks assigned by the Workshop Leaders as part of the demonstration. Please make sure you feel confident to be in Group A.
Organised in Partnership with
We hope that you will have the opportunity to join us for this unique interactive and educational workshop format.
Should you know of someone who could be interested in this workshop, please feel free to share this announcement.
Keep updated with the EFGCP upcoming workshops, conferences and training courses by visiting our website at www.efgcp.eu or contact us at the EFGCP Secretariat (T: +32 2 732 87 83 – Email: conferences@efgcp.eu).
Kind regards,
The EFGCP Team
Square de Meeûs - Rue de l'Industrie, 4
BE-1000 Brussels
Belgium
Tel: +32.2.732 87 83
Fax: +32.2.503 31 08
Email: conferences@efgcp.eu
Website: http://www.efgcp.eu
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