To keep pace with technologies. How to regulate new medicine?

RUBY HALL, October 17, 15:00 — 16:00

In international regulatory practice, there are special programs for the accelerated registration of innovative medicines and medical devices (breakthrough therapy, accelerated approval, a special program for antibiotics effective for infections caused by highly resistant microorganisms). Special consultations of the applicants with the regulatory agencies or centers (FDA, EMA, PMDA, KFDA etc.) at all stages of the development make it possible to maintain the most efficient dialogue between the developer and the authorized authority.