Introduction In April 2008, I am put up as Cardiovascular medical Leader for a geographic region c everyed intercontinental and including the emerging markets plus countries as Japan, Australia and Canada. It is virtually 2 third of the globe. This position covers Clinical Development, Regulatory personal matters and Medical Affairs. I do manage most 50 people with 4 direct reports. It is a new pedigree position, as for the company and as for me, and I have 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 launch in a warring environment an anti platelet drug in Asia. Prioritized countries in Asia are 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 nearby 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 happen in 2009. The signifier deuce-ace trial results are showing a give net clinical benefit in favor of our heterogeneous versus the standard of care (clopidogrel).
The results are also showing that the unhopeful body weight patients, the elderly and those with a history of fortuity are at high risk of bleedings with our compound. Unfortunately, Asian patients are globally lighter and older than Caucasian patients; they also fall in a more frequent history of stroke. There has been no Asian patient included 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 operation 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 committee for the region: I...If you wish to get a full essay, order it on our website: Orderessay
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