March 12, 2014
FoREMS & More: 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.
- 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
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