TY - BOOK ID - 1668725 TI - Clinical trials in Belgium : The Belgian implementation of the European clinical trials directive : an operational guidance AU - Trouet, Caroline AU - Gobert, Marjorie AU - Podoor, Monique PY - 2007 SN - 9789050956871 9050956874 PB - Antwerp: Intersentia, DB - UniCat KW - Professional ethics. Deontology KW - medische ethiek KW - medische experimenten KW - Medical law KW - Pharmacology. Therapy KW - Belgium KW - Clinical Trials KW - QV 771 Standardization and evaluation of drugs KW - European Union KW - Clinical Trials as Topic KW - Randomized Controlled Trials as Topic KW - Ethics, Clinical KW - Legislation, Drug KW - Legislation, Medical KW - 34 EU KW - 351.84*7 KW - 615 <493> KW - Medische experimenten : wetgeving KW - 611.08 KW - Wet van 7 mei 2004 inzake experimenten op de menselijke persoon KW - klinische proef (klinische studie, geneesmiddelenstudie) KW - commissie voor medische ethiek (ethisch comité, CME) KW - 351.84*7 Medisch recht. Gezondheidsrecht. Wetgeving i.v.m. ziekenhuizen KW - Medisch recht. Gezondheidsrecht. Wetgeving i.v.m. ziekenhuizen KW - 34 EU Rechtswetenschappen.--EU KW - Rechtswetenschappen.--EU KW - Farmacologie. Farmaceutische wetenschappen--België KW - Loi du 7 mai 2004 relative aux expérimentations sur la personne humaine KW - essai clinique (étude clinique) KW - comité d'éthique médicale (comité d'éthique, CEM) KW - Clinical Trials as Topic - Belgium KW - Randomized Controlled Trials as Topic - Belgium KW - Ethics, Clinical - Belgium KW - Legislation, Drug - Belgium KW - Legislation, Medical - Belgium KW - Droit médical KW - Clinical trials KW - Droit de la santé KW - Bioéthique KW - Medicaments KW - Belgique KW - recherche scientifique KW - expérimentations humaines KW - essais cliniques UR - https://www.unicat.be/uniCat?func=search&query=sysid:1668725 AB - 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. ER -