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GMP Convergence – A Key Part of Regulatory System Strengthening

Track:
Drug Development and Regulatory Approval - Reference Points around the Globe or Globalisation?

Day & Time:
April 19, 8:30AM - 10:00AM (Central Europe Standard Time)

Session Number:
S0804

Room Number:
Shanghai 3

Level:
Intermediate

Type:
Session

Title:
GMP Convergence – A Key Part of Regulatory System Strengthening

Chair(s):
Barbara Allen, PhD
Senior Director Global Quality Systems
Eli Lilly and Company, Ireland

Description:
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(s):
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

Presentation(s) & Speaker(s):
GMP Convergence – Industry Perspective
Stephan Roenninger, DrSc
Director, External Affairs Europe, International Quality
Amgen (Europe) GmbH, Switzerland

WHO Activities on Regulatory System Strengthening
Alireza Khadem Broojerdia
Scientist, Regulatory Systems Strengthening (RSS)
WHO, Switzerland

GMP Harmonisation and GMP Inspection Reliance from a PIC/S Perspective
Meow Hoe Boon
Deputy Director
Health Sciences Authority, Singapore