Key Resources

Rationale

Given the wide variety of global regulatory requirements, managing the volume, variety and velocity of pharmacovigilance data presents a significant challenge. Operations that are repetitive in nature and of relatively low business value are ripe for automation to gain efficiencies and reduce costs.

The Intelligent Automation Initiative focuses on identifying how intelligent automation technologies can be used to better support execution of Pharmacovigilance activities/processes. By conducting an impact assessment and working with global health authorities to verify risks/issues with their use, this initiative will provide guidance, as appropriate, on applications of new technology in Pharmacovigilance practice.

Benefits

Near term

  • Enhanced quality and speed through automation
  • Greater consistency within a particular sponsor company’s case processing and reporting while limiting errors commonly associated with manual data processing
  • Potential reallocation of resources to address more value-adding opportunities

Longer term

  • Catalyst for third party innovation in intelligent automation

Available Assets

The Initiative assets below are currently targeted for completion in Q3-Q4 2019:

  • Utilizing Advanced Technologies to Augment Pharmacovigilance (PV) Systems: This whitepaper would help facilitate understanding of intelligent automation technology related terms in the PV context and present overall challenges and opportunities for PV
  • Individual Case Safety Report Process Heat Map: The online tool and whitepaper will provide understanding of where opportunities for intelligent automation are in the ICSR process, and the level and type of benefits that could be achieved
  • Guidance for Validation of Automated Pharmacovigilance Systems: The whitepaper will provide guidance to the industry on validation strategies being utilized and to facilitate dialogue with Health Authorities on this topic

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