This symposium will critically examine the practical challenges associated with effective implementation of ICH Q3D.The Guideline was finalised in December 2014 and the implementation date in Europe for new products is June 2016.
This symposium will aim to provide those faced with the challenges arising from implementation with clear and affective guidance on how Q3D can be implemented, taking into account the views of both industry and regulatory experts.
The symposium will examine how to apply a risk-based approach and how this can be used to identify those areas critical to implementation, including the role that data plays in the process, how knowledge can be leveraged, and the practical aspects associated with sample analysis.
This symposium will aim to provide those faced with the challenges arising from implementation with clear and affective guidance on how Q3D can be implemented, taking into account the views of both industry and regulatory experts.
The symposium will examine how to apply a risk-based approach and how this can be used to identify those areas critical to implementation, including the role that data plays in the process, how knowledge can be leveraged, and the practical aspects associated with sample analysis.
