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Life Cycle Management – The Unknown Barrier to Access
Session Chair(s)
Ursula Busse, PHD, MBA
CMC Regulatory Affairs Advisor
Self employed, France
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
Speaker(s)
International Efforts to Ensure Sustained Product Supply over its Life Cycle
Thomas Schreitmueller, DRSC
F. Hoffmann - La Roche AG, Switzerland
Global Head Regulatory Policy; F. Hoffmann - La Roche Ltd.
Life Cycle Management – Fast Track or Hurdle Race?
Nadia Beaudoux, PHARMD
Lilly, France
Regulatory Affairs Consultant
ICH Q12: Solutions to Facilitate Post-Approval Change Management throughout a Product’s Life Cycle
Jean-Louis Robert, PHD
Luxembourg
Former CHMP/CVMP QWP Chair