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

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