Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
Language-related issues come up quite frequently. Most interactions with regulators are held in English, but not all of them. In China, it is Mandarin, and in Japan it is, well, Japanese. In Europe, it is mostly English, but French and German occasionally creeps into the dialogue. In China, even if Continue reading REGULATORY INTERACTIONS – 2 The “KATA” of Proper Behavior
We have often mentioned the central importance of microbiological response as an endpoint in trials of antibacterials. This is contrary to other therapeutic areas, in which the etiology is less understood and where surrogate markers are needed. In bacterial infectious diseases we have the luxury of knowing exactly what causes Continue reading Microbiological Response as Primary Efficacy Endpoint for Antibacterials
It can feel like the mountain stage of the Tour de France… A lot of effort goes into preparing for meetings with Regulators. There is also a lot we can learn at such meetings. Today we start a series of blogs detailing personal experiences and learnings, highlighting do’s and don’ts. Continue reading REGULATORY INTERACTIONS – 1