Cell Therapy Manufacturing, Gebunden

Blurb

The development of gene edited cell therapies: challenges and solutions .- Combined advanced therapies: challenges and solutions.- Developing advanced therapies in a challenging patent and legal environment: perspectives on current and future cell therapies .- Developing Ethical perspectives on advanced therapies and future challenges .- Modelling adequate reimbursement for cell therapies .- Facilitating international coordination of manufacturers and regulators .- The future of reference materials for cell therapies .- Experiences Development of ISO standards for cell therapies .- NIST activities in development of standards for cell therapies .- FIRM and Japanese standardization initiative for regenerative medicine .- The industry perspective: ARM SBC and ASTM .- Development of cell therapy regulation: the Japanese experience.- MFDS and Korean regulation .- Australian approaches to regulation .- EU regulatory processes for cell therapy applications .- Canadian cell therapyregs .- Development of cell therapy regulation: the US perspective.