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

• Date:
  Tuesday, 28 January 2014, All day
• 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

Presentation - Introduction and goals of the workshop (Jean-Louis Robert)

Presentation - Introduction and goals of the workshop (Georges France)

Presentation - Case study 1- Risk assessment and lifecycle management learning

Presentation - Case study 2 - Development and verification of design space

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

Summary:

Case Study 3 - Applying QbD for a legacy product and achieving real time release testing bya design space approach with supportive PAT and soft sensor based models: Challenges in the implementations

Presentation - Case Study 4 - Challenges in the implementation of model based and PAT based RTRT for a new product

Presentation - Case Study 5 - Control strategy

Presentation - Case Study 6 - Novo Nordisk experience in the application of QbD

Presentation - EU variations system

Presentation - FDA Reflections on Joint Regulators/Industry QbD Workshop (Christine M. V. Moore)

Presentation - PMDA perspectives (Yoshihiro Matsuda)

Presentation - Innovation in medicines and manufacturing (David Tainsh, Keith Pugh)

Presentation - Closing remarks (David Tainsh, Keith Pugh)

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