Date
- Tuesday, 28 January 2014
Location
- European Medicines Agency, Amsterdam, the Netherlands
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.
Documents
Agenda - Joint European Medicines Agency/Parenteral Drug Association quality-by-design workshop
English (EN) (774.77 KB - PDF)
Presentation - Introduction and goals of the workshop (Jean-Louis Robert)
English (EN) (468.15 KB - PDF)
Presentation - Introduction and goals of the workshop (Georges France)
English (EN) (979.53 KB - PDF)
Presentation - Case study 1- Risk assessment and lifecycle management learning
English (EN) (884.91 KB - PDF)
Presentation - Case study 2 - Development and verification of design space
English (EN) (900.87 KB - PDF)
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 (EN) (1.92 MB - PDF)
Presentation - Case Study 4 - Challenges in the implementation of model based and PAT based RTRT for a new product
English (EN) (1.6 MB - PDF)
Presentation - Case Study 5 - Control strategy
English (EN) (646.1 KB - PDF)
Presentation - Case Study 6 - Novo Nordisk experience in the application of QbD
English (EN) (1.29 MB - PDF)
Presentation - EU variations system
English (EN) (581.11 KB - PDF)
Presentation - FDA Reflections on Joint Regulators/Industry QbD Workshop (Christine M. V. Moore)
English (EN) (234.07 KB - PDF)
Presentation - PMDA perspectives (Yoshihiro Matsuda)
English (EN) (425.25 KB - PDF)
Presentation - Innovation in medicines and manufacturing (David Tainsh, Keith Pugh)
English (EN) (1.74 MB - PDF)
Presentation - Closing remarks (David Tainsh, Keith Pugh)
English (EN) (330.67 KB - PDF)
Multimedia
Video recording
A video recording is now available.
To view use the 'Multimedia' tab.
Note: The presentation on 'Learning and best practices from the case studies' will be published at a later stage.