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International Efforts to Ensure Sustained Product Supply over its Life Cycle

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

Day & Time:
April 19, 10:30AM - 12:00PM (Central Europe Standard Time)

Session Number:
S0805

Room Number:
Shanghai 3

Level:
Intermediate

Type:
Session

Title:
Life Cycle Management – The Unknown Barrier to Access

Chair(s):
Ursula Busse, PhD, MBA
Head of Quality Intelligence, External Engagement
Novartis, Switzerland

Description:
The lack of a harmonised global regulatory framework for post-approval changes leads to supply chain complexity, hinders manufacturing innovation, increases the risk of quality failures and contributes to the issue of global and country specific drug shortages. This session will cover current challenges and highlight ongoing initiatives towards a sustainable global environment for pharmaceutical product life cycle management

Presentation(s) & Speaker(s):
International Efforts to Ensure Sustained Product Supply over its Life Cycle
Thomas Schreitmueller, DrSc
Global Head Regulatory Policy; F. Hoffmann - La Roche Ltd.
F. Hoffmann - La Roche Ltd, Switzerland

Life Cycle Management – Fast Track or Hurdle Race?
Nadia Beaudoux, PharmD
Regulatory Affairs Consultant
Lilly, France

ICH Q12: Solutions to Facilitate Post-Approval Change Management throughout a Product’s Life Cycle
Jean-Louis Robert, PhD
Former CHMP/CVMP QWP Chair
Luxembourg