Developing a Single Product for Multiple Markets
Meeting the manufacturing requirements of FDA, EMEA and TGA is a common challenge for those undertaking product development in the context of multicentre studies.
When optimising a product to ensure its commercial viability what can be done to pre-empt likely concerns of multiple regulators?
This webinar will take you through the common issues and points of difference between each regulator. As well as addressing the challenges and opportunities when using manufacturing sites on three continents.
At which point should automation and introduction of closed systems be optimally considered?
Dominic will also explore product development, biomaterials, comparability, stability and in process and release testing as well as product characterisation.
Presenters:
Dominic Wall
PhD FFSc (RCPA)
Cell Therapies
