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The Ask:

A joint venture company was established in 1994 between the vaccine divisions of two global organisations to focus on marketing vaccines successfully in its territories.  A joint venture is an unusual commercial arrangement and brings its own challenges in managing the business in a highly regulated industry.  Explic8 consultants were asked to:

  • simplify and harmonize its current business processes into an integrated holistic process set that affords improved protection of patient safety and continues to meet all current and upcoming regulations, local capabilities, needs of its affiliates and shareholder requirements;
  • consolidate the safety management landscape from an organizational, process and technical perspective to improve performance and efficiency; and
  • take advantage of advancements in technology to realize the potential benefits of a new Safety Database implementation

Challenges:

  • Data entered into process from 12 disparate groups;
  • There were 8 different process variations between the groups;
  • There was variability in the time taken for each of the process steps
  • Process heavily paper dependent;
  • Case file took four days on average to complete;
  • Submission compliance targets were not being achieved;
  • Company was facing increasing pressure to improve timelines and submission compliance;
  • This review had to be conducted in a very short space of time because the company was preparing for another imminent inspection.

Implications

  • Risk of non-compliance
  • Team was operating under pressure and had hosted 18 audits and inspections without critical findings during the year.

Objectives

  • Simplify and harmonize its current business processes; and
  • Improve compliance performance (internal and external)

The Approach:

  • Interviews conducted with:
  • Affiliate Offices,
  • Vaccine Safety Assistants,
  • Vaccine Safety Managers,
  • Vaccine Safety Data Managers,
  • Vaccine Safety Officer,
  • All PVRM Division Heads.
  • “As is” ICSR process & Risk Management workshop held;
  • Case timing data collected from Corporate and Affiliates
  • SOPs reviewed (Case Processing, Safety Monitoring, Crisis Management);
  • Data from ARISg, AESI, RMPs and Safety Findings reviewed;
  • Findings compared to Industry Benchmark data.