WHITEPAPER

LifeSphere® Safety:

Extending a Worldwide Pharmacovigilance Program to the Japanese Market

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Most global companies have come to grips with the regulatory requirements of the major regulatory authorities, which have mandated the electronic submission of safety data for clinical safety reports (SUSARs) and spontaneous reports (ICSRs). However, companies continue to face the challenge of meeting the unique requirements from the Japanese regulators. The Ministry of Health, Labor and Welfare (MHLW) has defined a unique set of requirements for the collection, assessment and reporting of adverse event data in Japan.

This paper summarizes ArisGlobal’s LifeSphere® Safety global solution for the Japanese market.

Learn about:

  • Challenges related to Japanese domestic and foreign case reporting to MHLW
  • Increasing number of cases reported to PMDA
  • The benefits of LifeSphere Safety MultiVigilance, a single comprehensive clinical safety and pharmacovigilance case management system to support Japanese domestic adverse event reporting
  • Key features, including automation of routine manual tasks, a fully configurable case processing system, a MedDRA browser providing the ability to automatically code terms, ability to track all communications and collaboration and sharing of case information between major ICH regions.