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July 9, 2014

FoREMS & More: Case Study: Applying Quality Risk Management (QRM) Principles - Findings of Systematic Risk Assessment for Risk Based Monitoring

Wednesday, July 9, 2014

12 pm New York time, 9 am California time, 5 pm London time

QRM principles described in ICH Q-9 offer a roadmap for systematic assessment, control, communication, and monitoring of risks – collectively “risk management” – in any functional area of pharmaceutical or medical device manufacturers.  Successful risk management requires QRM expertise, functional subject matter expertise, and a specified goal.  This webinar will feature a description of the application of these methods to complete a systematic risk assessment and risk control plan for the monitoring of a clinical study.  

This webinar will highlight:

  • Key success factors and selected findings
  • An overview of ways to apply these methods to other functions such as drug safety risk management


  • Kris Srinivasan – Director, Clinical Consulting, ParagonRx
  • Marc DeLuca – Associate Director, Clinical Consulting, ParagonRx

Our 45 minute presentation will be followed by a 15 minute interactive Q&A.

To download a copy of the slides from this presentation, click here.

To view the recording of this webinar, click here.

To speak to a ParagonRx team member about our monthly webinars
call 888.459.8080 or email