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Global Pharmaceutical Regulatory Affairs Summit
22-24 October 2024
Sheraton Brussels Airport, BrusselsHybrid Event

Akira Yamaguchi
Chief Technology Officer at LORENZ Life Sciences Group


After an international career in management consulting and information technology, Akira joined LORENZ in 1995. Akira's initial field of activity has been electronic submission projects at regulatory agencies and pharmaceutical companies. In 2003 he became responsible for LORENZ's overall software product development.

Regarding eCTD, Akira's involvements are:

  • Development of regional eCTD 3.2 specifications (e.g. Australia, Canada, China, Singapore)
  • Implementation of agency review systems for eCTD 3.2 (e.g. CDE, Health Canada, US FDA)
  • Implementation eCTD 4.0 publishing for industry to participate in pilots for PMDA and FDA.
  • Implementation of pilot review system for the FDA eCTD 4.0 pilot

Agenda Sessions

  • A Conceptual Overview of Industry Trends and the Impact on Submission Content, Process and Technology