Resources

Webinars

Return to listings page

December 10, 2014

FoREMS & More: A Systematic Approach to Risk Control

Risk Controls.  The EU Guideline on Good Pharmacovigilance Practices Module XVI refers to these as risk minimization measures.  The FDA Draft Guidance on Format and Content of Proposed REMS refers to these as REMS elements.  ICH Q9 Guidance on Quality Risk Management refers to these as risk controls.  In all cases, the intent is to reduce or accept risks that have been identified in the risk assessment stage of an overall risk management process.  Selection of appropriate risk controls or risk minimization measures may seem challenging, but ICH Q9 offers a blueprint.  This webinar will provide an overview of regulatory requirements for risk minimization measures, a review of challenges reported by risk managers in the selection of risk controls, and a description of how ICH Q9 supports a systematic approach to risk control.

This webinar will highlight:
  • An overview of regulatory requirements for risk minimization measures
  • A review of challenges reported by risk managers in the selection of risk controls
  • A description of how ICH Q9 supports a systematic approach to risk control
  • Case examples
Presenting this webinar:
  • Jeff Fetterman, President, ParagonRx International LLC, an inVentiv Health company

To view the slides presented during this webinar click here.

To view the replay of this webinar click here.


To speak to a ParagonRx team member about our monthly webinars
call 888.459.8080 or email info@paragonrx.com