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Questions and Answers
Quel est le but principal des protocoles de biosécurité?
Quel est le rôle de l'Agence européenne des médicaments (EMA) ?
Quel est le nom de la directive qui établit des normes pour le bien-être des animaux utilisés à des fins scientifiques?
Quel est le rôle de la Food and Drug Administration (FDA) aux États-Unis?
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Quel est le but principal de la Bonne Pratique de Laboratoire (GLP) ?
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Quel est le but principal de l'obtention du consentement éclairé ?
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Study Notes
Legislation in Applied Biochemistry
International Regulations
- Biosafety protocols: Guidelines for handling and storing biological materials, ensuring safe working practices, and preventing environmental release of genetically modified organisms (GMOs).
- Good Laboratory Practice (GLP): International standards for laboratory operations, including testing, data management, and reporting.
- Good Manufacturing Practice (GMP): Regulations for the production of pharmaceuticals, biologics, and medical devices, ensuring quality, purity, and safety.
National Regulations
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USA:
- Food and Drug Administration (FDA): Oversees the development, approval, and regulation of biochemistry-related products, including pharmaceuticals, biologics, and medical devices.
- National Institutes of Health (NIH): Provides guidelines for research involving recombinant DNA, human subjects, and animal research.
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European Union:
- European Medicines Agency (EMA): Regulates the development, approval, and marketing of biochemistry-related products, including pharmaceuticals and biologics.
- Directive on the protection of animals used for scientific purposes: Sets standards for animal welfare and research involving animals.
Ethical Considerations
- Informed consent: Obtaining permission from human subjects participating in research, ensuring they understand the risks, benefits, and purpose of the study.
- Confidentiality and data protection: Protecting sensitive information and ensuring privacy of research participants.
- Animal welfare: Ensuring the humane treatment and care of animals used in research, and minimizing harm and distress.
Intellectual Property and Patent Law
- Patent protection: Securing exclusive rights for inventions, including biotechnological innovations, to encourage innovation and investment.
- Intellectual property rights: Protecting proprietary information, trade secrets, and copyrights related to biochemistry research and development.
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Description
Test your knowledge of international and national regulations, ethical considerations, and intellectual property laws in applied biochemistry. Learn about biosafety protocols, good laboratory and manufacturing practices, and regulations in the USA and EU. Understand informed consent, animal welfare, and patent protection.
