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Les découvertes de la biologie moderne débouchent sur des techniques de "manipulations génétiques" qui offrent à l'homme le pouvoir d'intervenir dans l'évolution naturelle et de modifier les mécanismes de l'hérédité mais est-ce Prométhée ou Pandore qui s'avance vers nous ? La controverse a fait rage dans les milieux scientifiques eux-mêmes sur les risques de création et de dissémination, au cours de telles expériences, de dangereuses espèces microbiennes inconnues. Mais, par-delà ces dangers réels, se pose la question du rôle social que l'on veut faire jouer à la biologie. Fournit-elle vraiment le meilleur moyen de lutter contre la faim et la maladie dans le monde ? Le remède ne sera-t-il par pire que le mal ? Comme la physique jadis avec l'énergie nucléaire, la biologie avec les manipulations génétiques perd son innocence. La science est affaire trop sérieuse pour être laissée aux seuls scientifiques. Voici les éléments techniques et politiques, de l'indispensable débat public.
Genetic engineering --- Genetische manipulatie --- 241.63*5 --- 611.08 --- Designed genetic change --- Engineering, Genetic --- Gene splicing --- Genetic intervention --- Genetic surgery --- Genetic recombination --- Biotechnology --- Transgenic organisms --- Manipulations génétiques --- Theologische ethiek: bio-ethiek (bioethiek); genetische experimenten; transplantatie; eugenetica --- Genetic engineering. --- 241.63*5 Theologische ethiek: bio-ethiek (bioethiek); genetische experimenten; transplantatie; eugenetica --- Génie génétique --- Aspect social. --- Social aspects --- Aspect social --- Génie génétique
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Animal experimentation --- Expérimentation animale --- Moral and ethical aspects --- Aspect moral --- #ABIB:aimm --- 619 --- $?$96/08 --- 611.08 --- 614.22 --- 591.084 --- 179.4 --- Zoology and Animal Sciences. Zoology --- Moral and ethical aspects. --- Animal Experimentation --- Animal Experimentation. --- Expérimentation animale --- Animal Rights. --- Animals, Laboratory. --- Animal Rights --- Animals, Laboratory --- Animal testing alternatives
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Drugs --- Infants --- Research --- Human Experimentation --- Ethics, Medical --- Testing --- Moral and ethical aspects --- Effect of drugs on --- Ethics, Medical. --- Human Experimentation. --- Research. --- -Drugs --- -611.08 --- 615 --- Medicaments --- Medications --- Medicine (Drugs) --- Medicines (Drugs) --- Pharmaceuticals --- Prescription drugs --- Bioactive compounds --- Medical supplies --- Pharmacopoeias --- Chemotherapy --- Materia medica --- Pharmacology --- Pharmacy --- Babies --- Infancy --- Children --- Laboratory Research --- Research Activities --- Research and Development --- Research Priorities --- Activities, Research --- Activity, Research --- Development and Research --- Priorities, Research --- Priority, Research --- Research Activity --- Research Priority --- Research, Laboratory --- Ethics, Research --- Human Research Subject Protection --- Experimentation, Human --- Helsinki Declaration --- Bioethical Issues --- Embryo Research --- Fetal Research --- Research Subjects --- Medical Ethics --- Medicine --- Professionalism --- Bioethics --- -Moral and ethical aspects --- ethics --- Human experimentation in medicine --- 611.08 --- Drugs and infants --- Pediatric pharmacology --- Testing&delete& --- Physiological effect --- Drugs - Testing - Moral and ethical aspects --- Infants - Effect of drugs on
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I. Historiek bij de wet van 7 mei 2004 inzake experimenten op de menselijke persoon - II. Schema van de wet - III. Artikelsgewijze bespreking
gezondheidsrecht --- Tort and negligence --- medische ethiek --- medische experimenten --- Medical law --- Belgium --- Ethique médicale --- Législation --- Medische ethiek --- Wetgeving --- Human experimentation in medicine--Law and legislation--Belgium. --- Medical ethics--Belgium. --- 674 Gezondheidsrecht --- 061 Ethische problemen --- 614.1 --- ethiek (gez) --- experimenten --- wetgeving (gez) --- 601.7 --- patiëntenrecht --- patiëntveiligheid (veiligheid patiënt) --- 611.08 --- Medische experimenten : wetgeving --- België --- Medische experimenten --- Recht en ethiek --- Recht --- Wet van 7 mei 2004 inzake experimenten op de menselijke persoon --- experiment, experimenteel onderzoek (mensen) --- 13.12 --- (zie ook: beveiliging) --- Loi du 7 mai 2004 relative aux expérimentations sur la personne humaine --- expérimentation sur la personne humaine (chez l'humain) --- Wettelijke en contractuele aansprakelijkheid ; Geneesheren ; Veeartsen ; Apothekers ; Tandartsen ; Paramedici --- Human experimentation in medicine --- Law and legislation --- Provincie West-Vlaanderen --- Medical ethics--Belgium --- Professional ethics. Deontology --- Law --- recht --- bio-ethiek --- Human experimentation in medicine - Law and legislation - Belgium --- DROIT DE LA SANTE --- Bioéthique --- EXPERIMENTATIONS MEDICALES --- Essais cliniques --- Recherches biomédicales --- médicaments expérimentaux --- BELGIQUE
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Status of persons --- Professional ethics. Deontology --- Medical law --- Comparative law --- Droit comparé --- Experimentation on man [Medical ] --- Expériences médicales sur l'homme --- Geneeskundige proefnemingen op de mens --- Human experimentation in medicine --- Medical experimentation on humans --- Proefnemingen [Geneeskundige ] op de mens --- Rechtsvergelijking --- Deontologie --- Déontologie --- Ethique philosophique --- Geneeskunde --- Médecine --- Wijsgerige ethiek --- Expérimentation humaine en médecine --- Moral and ethical aspects --- Law and legislation --- Aspect moral --- Droit --- Expérimentation médicale --- Homme --- --Médicament --- --Expérience --- --Bioéthique --- --Corps humain --- --Éthique --- --7658 --- #gsdb5 --- #GBIB:CBMER --- 611.08 --- 615 --- 241.63*5 --- 17.023.33 --- experiment, experimenteel onderzoek (mensen) --- deontologie (plichtenleer, deontologische code, deontologische richtlijn, professionele integriteit) --- geneesmiddelen --- normatieve ethiek --- ethiek (ethische aspecten) --- expérimentation sur la personne humaine (chez l'humain) --- déontologie (code de déontologie, code de conduite, code de pratiques) --- médicaments --- éthique normative --- ethique (aspects ethiques) --- Expérimentation humaine en médecine --- Medicine --- Research --- --Homme --- --Human experimentation in medicine --- --#gsdb5 --- Médicament --- Expérience --- Bioéthique --- Corps humain --- Éthique --- Human experimentation --- Ethics --- Legislation --- Expérimentation humaine --- Éthique des médecins --- Éthique médicale --- Belgium
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In line with its strong position in clinical research, Belgium was one of the first European Member States where the implementing regulation of the Clinical Trials Directive is fully operational. The specific conditions provided for in the legislation concerning experiments on the human person reinforce Belgium as a very attractive host for clinical trials, ensuring a lasting environment for innovative research.Pharma.be, the Belgian Pharmaceutical Industry Association, wants to contribute its part to research in Belgium by clarifying the practical implications of the new regulations. This new edition of the Operational Guidance does not only analyse the Belgian law from the perspective of the sponsor of a clinical trial, but also addresses the roles and tasks of all parties involved in clinical trials. In order to assist everyone involved in clinical trials, the Guidance provides for a short and comprehensive overview and insight into the process flows of the submission to and evaluation by the competent authority and the ethics committee of a clinical trials application. In addition, standard templates for the most important documents are added on a cd rom.This book is extremely useful, both for study sponsors and for all other actors in the field of medical research and development such as members of ethics committees, physicians, pharmacists, administrators, etc.The first edition of Clinical Trials in Belgium was very soon qualified as the standard textbook on the new EU legal framework and its transposition into Belgian law.
Professional ethics. Deontology --- medische ethiek --- medische experimenten --- Medical law --- Pharmacology. Therapy --- Belgium --- Clinical Trials --- QV 771 Standardization and evaluation of drugs --- European Union --- Clinical Trials as Topic --- Randomized Controlled Trials as Topic --- Ethics, Clinical --- Legislation, Drug --- Legislation, Medical --- 34 EU --- 351.84*7 --- 615 <493> --- Medische experimenten : wetgeving --- 611.08 --- Wet van 7 mei 2004 inzake experimenten op de menselijke persoon --- klinische proef (klinische studie, geneesmiddelenstudie) --- commissie voor medische ethiek (ethisch comité, CME) --- 351.84*7 Medisch recht. Gezondheidsrecht. Wetgeving i.v.m. ziekenhuizen --- Medisch recht. Gezondheidsrecht. Wetgeving i.v.m. ziekenhuizen --- 34 EU Rechtswetenschappen.--EU --- Rechtswetenschappen.--EU --- Farmacologie. Farmaceutische wetenschappen--België --- Loi du 7 mai 2004 relative aux expérimentations sur la personne humaine --- essai clinique (étude clinique) --- comité d'éthique médicale (comité d'éthique, CEM) --- Clinical Trials as Topic - Belgium --- Randomized Controlled Trials as Topic - Belgium --- Ethics, Clinical - Belgium --- Legislation, Drug - Belgium --- Legislation, Medical - Belgium --- Droit médical --- Clinical trials --- Droit de la santé --- Bioéthique --- Medicaments --- Belgique --- recherche scientifique --- expérimentations humaines --- essais cliniques
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