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March 12, 2014

FoREMS & More: Systematic Risk Management: An Overview of ICH Q-9

Systematic Risk Management:  An Overview of ICH Q-9

Global regulatory authorities have stated expectations for more  systematic and standardized risk management methods in the design and implementation of REMS and RMPs. For example, last year FDA conducted a public meeting on REMS Standardization and Evaluations as one step toward fulfillment of their PDUFA V goals.  Also, Modules V and XVI of the EU Good Pharmacovigilance Practices Guidelines specify that risk minimisation activities should be science-based and developed by suitable qualified people.  Where do risk management professionals go to look for a roadmap to systematic risk management?  This webinar makes the case for using ICH Q-9 as a roadmap for systematic risk management.  These guidelines offer the principles of Quality by Design (QbD) to many pharmaceutical functions ranging from manufacturing to risk based monitoring.

Key topics:

  • Rationale for systematic and standardized risk management methods
  • Overview of ICH Q-9
  • Why this is important to risk management professionals
  • How to get started and communicate these methods to business executives


  • Jeff Fetterman, President, ParagonRx
  • Stephen Sun, Chief Medical Officer, ParagonRx

To view the recording of this webinar, click here.

To view only the slides from this webinar, click here.

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