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- Published online November 21, 2013.
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© PDA, Inc. 2013
Author Information
- 1School of Chemical and Pharmaceutical Science, Dublin Institute of Technology, Dublin, Ireland; and
- 2Irish Medicines Board, Bord Leigheasra na hÉireann, Dublin, Ireland
- ↵*Corresponding Author: Nuala Calnan, Regulatory Science Researcher, Pharmaceutical Regulatory Science Team (PRST), School of Chemical & Pharmaceutical Sciences, Dublin Institute of Technology, Kevin Street, Dublin, Ireland. Telephone: +353 87 978 6968, E-mail: nuala.calnan{at}mydit.ie
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Keywords
- The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
- ICH Q8 (R2) Product Development
- ICH Q9 Quality Risk Management (QRM)
- ICH Q10 Pharmaceutical Quality System (PQS)
- Implementation
- Operational excellence
- Six sigma
- Lean manufacturing
- innovation
- Continual improvement
- Senior and corporate management responsibilities
- Leadership
- Regional regulatory enforcement
- Knowledge creation and management.