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Session 5: Regulatory Harmonisation
Session Chair(s)
Jean-Louis Robert, PhD
Former CHMP/CVMP QWP Chair
Luxembourg
This session will focus on ICH and WHO activities and will provide a candid assessment of progress to date, current challenges and future opportunities. A panel discussion will follow three presentations from global experts representing industry, regulators and WHO.
Speaker(s)
WHO Harmonisation Initiatives
Luther Gwaza, PhD
World Health Organization (WHO), Switzerland
Team Lead-Pharmaceuticals Norms & Standards, Depart of Health Products Policy
Regulatory Harmonisation – Progress, Challenges and Opportunities
Jean-Louis Robert, PhD
Luxembourg
Former CHMP/CVMP QWP Chair
Regulatory Landscape – Balancing Innovation, Acceleration and Global Regulatory Harmonisation
Ron Ogilvie
Pfizer, United Kingdom
CMC Advisor