REGULATORY
PMDA to Begin Unannounced Regular Inspections in Wake of GMP Violations by Kaketsuken
The Pharmaceuticals and Medical Devices Agency (PMDA) has decided to conduct unannounced regular inspections of drug makers’ manufacturing facilities. Regular inspections are part of the PMDA’s regime of onsite inspections. The main targets of unannounced inspections will be manufacturing facilities…
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REGULATORY
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I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…





