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
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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

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01
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