Worldwide Harmonization of Pharmaceutical Authorization - A Guideline for an International Drug Approval System Modeled on European Law
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CONTRIBUTORS:
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UNIVERSITY / COLLEGE:
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YEAR:
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2007
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PUB TYPE:
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Thesis/Dissertation
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PAGES:
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8,
128 p.
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SUBJECT(S):
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None
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DISCIPLINE:
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Law
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HTTP:
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LANGUAGE:
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English
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PUB ID:
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103-445-661
(Last edited on
2008/10/09 07:54:18 GMT-6)
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SPONSOR(S):
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ABSTRACT:
Pharmaceutical Companies are becoming highly globalized. This widening of drug markets leads to an erosion of legislative powers of national governments. With trials and marketing of compounds and pharmaceuticals carried out in different countries, ensuring safety and effectiveness of drugs becomes increasingly problematic. Thus, international harmonization of pharmaceutical approval as well as monitoring of drugs belongs paramount. This can be done by modeling an international pharmaceutical authorization system on the European Decentralized Procedure with involvement of the International Conferences of Harmonisation.
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