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

Latest News

27
Jun2018

Over 300 members attend the June New York and London Nets Forum Meetings

Throughout June, Navitas Life Sciences hosted a series of forum meetings in London and...