Joint European Medicines Agency/Parenteral Drug Association quality-by-design workshop

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TitleJoint European Medicines Agency/Parenteral Drug Association quality-by-design workshop
Date28/01/2014 - 29/01/2014
LocationEuropean Medicines Agency, London, UK
SummaryThe 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.

All documents

Name Language First published Last updated
Agenda - Joint European Medicines Agency/Parenteral Drug Association quality-by-design workshop (English only) 2014-02-28  
Presentation - Introduction and goals of the workshop (Jean-Louis Robert) (English only) 2014-02-28  
Presentation - Introduction and goals of the workshop (Georges France) (English only) 2014-02-28  
Presentation - Case study 1- Risk assessment and lifecycle management learning (English only) 2014-02-28  
Presentation - Case study 2 - Development and verification of design space (English only) 2014-02-28  
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 (English only) 2014-03-03  
Presentation - Case Study 4 - Challenges in the implementation of model based and PAT based RTRT for a new product (English only) 2014-02-28  
Presentation - Case Study 5 - Control strategy (English only) 2014-02-28  
Presentation - Case Study 6 - Novo Nordisk experience in the application of QbD (English only) 2014-02-28  
Presentation - EU variations system (English only) 2014-02-28  
Presentation - FDA Reflections on Joint Regulators/Industry QbD Workshop (Christine M. V. Moore) (English only) 2014-02-28  
Presentation - PMDA perspectives (Yoshihiro Matsuda) (English only) 2014-02-28  
Presentation - Innovation in medicines and manufacturing (David Tainsh, Keith Pugh) (English only) 2014-02-28  
Presentation - Closing remarks (David Tainsh, Keith Pugh) (English only) 2014-02-28  

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Note: The presentation on 'Learning and best practices from the case studies' will be published at a later stage.