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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. 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.

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