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Quality by Design and Data-Driven Risk-Based Monitoring, 7 June 2017

The Clinical Research Facility-Cork will host a workshop on

Wednesday 7th June 2017

09:15 am - 13:30 pm

Dr Artem Andrianov : Quality by Design and Data-Driven Risk-Based Monitoring

In our workshop, we will devote our attention to implementation of innovative process – Risk-based Monitoring (RBM) and Risk based Quality Management. It will be a very interactive session with much involvement of participants.

4 tickets available

  • Price: 0,00 €
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Product Description

During the workshop we will address the following questions:

  • The pros/cons of RBM approach
  • Current challenges of centralized monitoring and on-site study
    monitoring
  • What components must a holistic RBM include?
  • The main goals & success metrics for RBM?
  • What is the potential of data quality improvements (including
    detection of misconduct/fraud) and patient safety
    improvements with RBM?
  • How the main RBM providers and their services/products differ (pros and cons of integrated solutions versus specialized solutions, i.e. all in one hand versus RBM specialized service provider)?
  • What RBM-launch strategy would be the smoothest and most
    efficient?
  • What is the potential for cost savings (if there is any)?
  • Specific examples for KRIs and relating thresholds and actions?
  • What are the pitfalls of RBM?
  • How to learn and understand the RACT (Risk assessment and categorization tool, risk prioritization and identification and risk control) tool?
  • IT Systems for RBM.