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GMP Convergence – A Key Part of Regulatory System Strengthening
Session Chair(s)
Barbara Allen, PHD
International Quality Expert, United States
GMP standards and associated inspections are important components of strong regulatory system. This session will explore approaches and progress on GMP standard convergence, aligned inspection processes and regulatory authority cooperation.
Learning Objective : Session participants will • Understand international efforts on the convergence of GMP standards and associated inspections. • Gain insights to the challenges and barriers to convergence • Explore strategies to advance convergence
Speaker(s)
GMP Convergence – Industry Perspective
Stephan Roenninger, DRSC
Amgen (Europe) GmbH, Switzerland
Director, Quality Compliance External Affairs
WHO Activities on Regulatory System Strengthening
Alireza Khadem Broojerdia
WHO, Switzerland
Team Lead, Regulatory System Strenghtening
GMP Harmonisation and GMP Inspection Reliance from a PIC/S Perspective
Meow Hoe Boon
Health Sciences Authority, Singapore
Deputy Director