Environmental risk assessment for medicinal products containing genetically modified organisms
| Autor: | Brigitte Anliker, Christian J. Buchholz, S. Longhurst |
|---|---|
| Rok vydání: | 2009 |
| Předmět: |
Marketing of Health Services
Clinical Trials as Topic Conservation of Natural Resources Organisms Genetically Modified business.industry Cell Transplantation Public Health Environmental and Occupational Health Authorization Context (language use) Genetic Therapy Risk Assessment Genetically modified organism Clinical trial Biological Therapy Environmental risk Risk analysis (engineering) Business Risk assessment Genetic Engineering Risk management Environmental risk assessment |
| Zdroj: | Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz. 53(1) |
| ISSN: | 1437-1588 |
| Popis: | Many gene therapy medicinal products and also some vaccines consist of, or contain, genetically modified organisms (GMOs), which require specific consideration in the environmental risk assessment (ERA) before marketing authorisation or clinical trial applications. The ERA is performed in order to identify the potential risks for public health and the environment, which may arise due to the clinical use of these medicinal products. If such environmental risks are identified and considered as not acceptable, the ERA should go on to propose appropriate risk management strategies capable to reduce these risks. This article will provide an overview of the legal basis and requirements for the ERA of GMO-containing medicinal products in the context of marketing authorisation in the EU and clinical trials in Germany. Furthermore, the scientific principles and methodology that generally need to be followed when preparing an ERA for GMOs are discussed. |
| Databáze: | OpenAIRE |
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