“.. the science that will inform and enable robust regulatory decisions by both influencing and informing the regulator and assisting the manufacturer in providing the knowledge base to deliver confidence in these products”.

EPSRC Centre Manufacturing Industrial Summit, 2012

 

Since our 2012 summit we have refined our work in regulatory science by seeking consensus on the research questions to be addressed and methods used. We have begun a major new EPSRC Centre project identifying preferred alternative approaches for autologous cell therapy manufacturing, a key enabler for the rapid take-up of clinician-led therapies. The work of our new Director, Nick Medcalf, has a strong regulatory science component. We have also begun to work with EPSRC and MHRA to define other areas for work by the research community.

 

 

“…building stronger links between the regulators and those who are regulated would be a vital step in overcoming the difficulties of GMP requirements.”

House of Lords Science and Technology Select Committee report on Regenerative Medicine, July