David Haddow

David Haddow is Operations Director of Altrika LTD

"I am a designated individual at a company called Altrika, which is based in Sheffield. We offer acell culturing service that delivers skin cells to patients in the UK with severe burns and chronic wounds, for whom few treatments are available.

"The company’s activities are diverse. We source cells from hospitals, and subsequently process, distribute and store them. Part of the process – the collection of cells and obtaining consent from donors – falls under the remit of the HTA’s regulation, as does cell storage. Inspection of the processing and distribution activity is the responsibility of the Medicines and Healthcare products Regulatory Agency (MHRA), which regulates the quality and safety of medicines.

"A joint inspection with both regulatory agencies, with an aligned inspection process, is therefore very sensible. Preparing for inspections is no trivial so a single inspection is a time-saver. This reduces time taken for assembling documents and bringing together staff, as well as streamlining the post-inspection burden and allowing more time toconcentrate on our core activity, which is preparing treatments for patients.

"We work in a fast-moving sector and it is important that new clinical approaches are regulated in an appropriate way, and that the public are aware of this. Investors in new technologies also need to be confident that the right regulatory framework is in place in order to plan effective clinical development programmes."