Applying Part 11 to the Implementation of Quality Management Software

FDA's approval of eladocagene exuparvovec-tneq (Kebilidi) makes that product the first FDA-approved gene therapy for treating AADC deficiency.

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

Manufacturers of five autologous or matched allogenic cell therapy products have selected TrakCel's IT platform, OCELLOS, to orchestrate the administration of these therapies, which are approved or expected to be approved in 2024.

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.

A £520 million investment for manufacturing capacity was announced by Chancellor of the Exchequer, Rachel Reeves, but academic and industry leaders stress the money should be used to train personnel.

Pharmaceutical training programs are enhanced by integrating ICH quality risk management considerations.