Safety Sciences Optimization: Local Risk Management
Are you challenged with global delivery of local Risk Management?
Are you challenged with global delivery of local Risk Management?
Development of a Risk Management system that delivers a global strategy and core position on product risks is key to successful implementation of local risk minimization
Key Issues Addressed
- Lack of oversight of local risk management document preparation
- Ineffective engagement of local resources in RM plan execution
- Inefficient RM document authoring and submission at the Affiliate level
- Inability to successfully track local Risk Management implementation
- Challenges complying with local Health Authority RM requirements
- Compliance exposure in measuring the effectiveness of RM activities
Navitas Life Sciences Provides an Integrated Approach Leading to Impactful Results
- Assessment of Risk Management Governance / local Affiliate engagement / implementation of Risk Management activities/technology solutions
- Develop improved processes and procedures that deliver a core risk management position but allow local adaptability based on best practice
- Implement integrated processes and governance spanning both global and local levels
Deliverables
- Risk Management document development process that delivers a consistent, global strategy and core position on product risks
- Refinement of SOPs, work instructions, templates and job aids to support Risk Management
- Identification and implementation of appropriate technology to implement and track risk management, specifically Risk Management Documents (RMD) and Risk Management Activities
- Support for the maintenance of risk management based on diverse local regulatory requirements that are continually evolving
Benefits
- Successful global implementation of risk minimization that is compliant with local health authority regulations
- Effective and compliant procedures to evaluate the effectiveness of risk management activities