Clinical Trial Initiation Procedures in Europe: The Legal Framework and Practical Aspects
| Autor: | C. Legrand, Ch. de Dupont, V. Laugel, F. Cheix, F. de Cremiers, H. Dumais |
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| Rok vydání: | 1995 |
| Předmět: |
European community
business.industry Public Health Environmental and Occupational Health Investigational New Drug Pharmacology (nursing) Legislation Context (language use) Public administration Clinical trial Risk analysis (engineering) Drug Guides Medicine media_common.cataloged_instance Pharmacology (medical) European union business Health policy Pharmaceutical industry media_common |
| Zdroj: | Drug Information Journal. 29:201-259 |
| ISSN: | 0092-8615 |
| DOI: | 10.1177/009286159502900126 |
| Popis: | This paper reports on the clinical trial initiation procedures in the European Community (EC) and the Nordic Countries. Procedures, regulatory evaluation structures, and ethical issues are analyzed and summarized. Differences from country-to-country are reviewed. There is a strong will in the EC to achieve a common and comprehensive drug policy. In this context, a harmonized and simplified system of common clinical trial regulation is desirable as long as it does not jeopardize the advantages offered by the present national procedures. In any case, such a common procedure has to avoid the disadvantages of the American investigational new drug, which is time consuming and inflexible. |
| Databáze: | OpenAIRE |
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