The chinaw atomic number 18ese Case Introduction In April 2008, I am put up as Cardiovascular medical attracter for a geographic region c everyed intercontinental and including the emergent markets plus countries as Japan, Australia and Canada. It is virtually 2 third of the globe. This take in covers Clinical Development, Regulatory personal matters and Medical Affairs. I do manage most 50 people with 4 account reports. It is a new pedigree position, as for the company and as for me, and I fork up to internally recruit my 4 direct reports. There ar all medical doctors and there ar all located in different countries. One of my missions is to build in a warring environment an anti thrombocyte drug in Asia. Prioritized countries in Asia argon China, South Korea, Taiwan and Japan. Key elements of the environment are cultural matters, regulatory rules, clinical standards, health economy policies and unrivalled competitor as a blockbuster (clopidogrel) prescribed for about 10 years and close to face generics. In April 2008, the anti platelet I have to launch in Asia has non been approved yet by the US agency (FDA) and by the European one (EMEA). It will bechance in 2009. The signifier deuce-ace trial results are video display a give net clinical benefit in favor of our heterogeneous versus the standard of care (clopidogrel).
The results are to a fault showing that the unhopeful body weight patients, the elderly and those with a history of fortuity are at high run a risk of bleedings with our compound. Unfortunately, Asian patients are globally lighter and older than Ca ucasian patients; they also fall in a more ! snitch history of stroke. There has been no Asian patient include into the pivotal Phase III trial. Phase I trials are showing a higher(prenominal) exposure in Asians. In April 2008, there is no Medical Director in Taiwan. The clinical performance teams as tumesce as the regulatory team are on their own and there is no synergy between them. Our compound is co developed with a Japanese company. We do have a joint venture steering commission for the region: I...If you wish to get a full essay, enounce it on our website: BestEssayCheap.com
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