Asian Management

The chinawargonese Case Introduction In April 2008, I am put up as Cardiovascular medical loss leader 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 vex covers Clinical Development, Regulatory personal matters and Medical Affairs. I do manage most 50 people with 4 govern reports. It is a new pedigree position, as for the company and as for me, and I pee-pee to internally recruit my 4 immediately reports. There ar all medical doctors and on that point ar all located in different countries. One of my missions is to instal in a warring environment an anti blood platelet drug in Asia. Prioritized countries in Asia atomic number 18 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 excrete in 2009. The signifier deuce-ace trial results are viewing a give net clinical benefit in favor of our heterogeneous versus the standard of care (clopidogrel).

The results are too showing that the unhopeful body weight patients, the elderly and those with a history of fortuity are at high gamble of bleedings with our compound. Unfortunately, Asian patients are globally lighter and older than Caucasian pat ients; they also fall in a more back up hi! story 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 effect 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 military commission for the region: I...If you wish to get a full essay, prepare it on our website: OrderCustomPaper.com

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