Joint European Medicines Agency/Parenteral Drug Association quality-by-design workshop
Date:
28/01/2014 to 29/01/2014
Location:
European Medicines Agency, London, UK
The EMA and the Parenteral Drug Association (PDA) organised the workshop to promote a common understanding of quality by design (QbD) and to share the experience gained since the first workshop organised in 2009 on the topic.
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Agenda - Joint European Medicines Agency/Parenteral Drug Association quality-by-design workshop (PDF/774.77 KB)
First published: 28/02/2014
Last updated: 28/02/2014 -
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Presentation - Introduction and goals of the workshop (Jean-Louis Robert) (PDF/468.15 KB)
First published: 28/02/2014
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Presentation - Introduction and goals of the workshop (Georges France) (PDF/979.53 KB)
First published: 28/02/2014
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Presentation - Case study 1- Risk assessment and lifecycle management learning (PDF/884.91 KB)
First published: 28/02/2014
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Presentation - Case study 2 - Development and verification of design space (PDF/900.87 KB)
First published: 28/02/2014
Last updated: 28/02/2014 -
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Presentation - Case Study 3 - Applying QbD for a legacy product and achieving real time release testing by a design space approach with supportive PAT and soft sensor based models: Challenges in the implementations (PDF/1.92 MB)
First published: 03/03/2014
Last updated: 03/03/2014 -
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Presentation - Case Study 4 - Challenges in the implementation of model based and PAT based RTRT for a new product (PDF/1.6 MB)
First published: 28/02/2014
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Presentation - Case Study 5 - Control strategy (PDF/646.1 KB)
First published: 28/02/2014
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Presentation - Case Study 6 - Novo Nordisk experience in the application of QbD (PDF/1.29 MB)
First published: 28/02/2014
Last updated: 28/02/2014 -
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Presentation - EU variations system (PDF/581.11 KB)
First published: 28/02/2014
Last updated: 28/02/2014 -
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Presentation - FDA Reflections on Joint Regulators/Industry QbD Workshop (Christine M. V. Moore) (PDF/234.07 KB)
First published: 28/02/2014
Last updated: 28/02/2014 -
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Presentation - PMDA perspectives (Yoshihiro Matsuda) (PDF/425.25 KB)
First published: 28/02/2014
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Presentation - Innovation in medicines and manufacturing (David Tainsh, Keith Pugh) (PDF/1.74 MB)
First published: 28/02/2014
Last updated: 28/02/2014 -
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Presentation - Closing remarks (David Tainsh, Keith Pugh) (PDF/330.67 KB)
First published: 28/02/2014
Last updated: 28/02/2014