Do you have Oversight of Your Affiliates?

From April 2015 – March 2016, the largest proportion of critical findings from MHRA PV inspectors was in relation to the supervision of the pharmacovigilance system, representing 28% of all critical findings identified including:

  • Lack of clarity on roles and responsibilities
  • Lack of oversight for delegated activities
  • Lack of process harmonization (e.g. intake / submission)
  • Inaccurate PSMF not giving current status of the system
  • Failure to provide complete and accurate information to national competent authorities
  • No QPPV access to global safety database
  • Lack of system integration

Navitas Life Sciences Provides an Integrated Approach Leading to Impactful Results

  • Affiliate Risk Management: Standardized questionnaires covering all PV Areas to quickly determine areas of greatest risk exposure
  • Operations and Capacity: Capacity / Capability Assessment to derive productivity, cost and utilization levels
  • Modeling Affiliate Governance: Assessment of fit of current affiliate operating model to support the business’s strategic direction
  • Dashboarding: To ensure ongoing visibility of key performance indicators allowing surfacing issues to be promptly addressed

Deliverables

  • Heat map visualizing local/ regional risks in Affiliates as well as systemic risks across PV functions
  • Charts and graphics informing management of productivity levels, resourcing patterns and areas for improvement
  • Holistic solution to address gaps in the global operating framework and approaches to strengthen the relationship between global and local entities including third parties such as Distributors and License Partners
heat map

Benefits

  • Affiliate Performance Insight & comparative performance
  • Proactive risk management
  • Streamlining of worldwide PV Operations
  • Identification of resource model fit
  • Tailored governance framework
  • Active monitoring of risk and resource metrics

Latest News

01
Dec2017

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