Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
In today’s blog we will share our thoughts about a recent NEJM article, entitled “A Phase 3 Trial of Telitacicept for Systemic Lupus Erythematosus”.[1] Publications on SLE literally come with a book of abbreviations and definitions nowadays and are not an easy Sunday reads. Of course, there is extensive literature Continue reading TELITACICEPT IN SLE
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
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