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

Amy Keum
Regulatory Submission Manager at Roche


Amy Keum is a Regulatory Submission Manager, in the Regulatory Data and Content Chapter within Product Development at Roche. With a major in Biochemistry from McMaster University and a post-graduate program in Pharmaceutical Regulatory Affairs and Quality Operations, Amy joined the Regulatory Affairs group in Canada where she gained invaluable knowledge of Health Canada submissions, before transferring to Global Regulatory Affairs for the past 5+ years. Amy is a go-to person for electronic submission systems and has in-depth experience in participating in regulatory pathways like Project Orbis, RTOR (Real-time Oncology Review) RTOR and ACCESS from a global submission perspective.

Agenda Sessions

  • Industry Case Study: Submitting under Project Orbis