TY - BOOK ID - 1504548 TI - Clinical trials in Belgium : the implementation of the European Clinical Trials Directive 2001/20/EC into the Belgian Law of May 7, 2004 concerning experiments on the human person : operational guidance PY - 2004 SN - 9050954200 9789050954204 PB - Antwerp: Intersentia, DB - UniCat KW - Pharmacology. Therapy KW - Medical law KW - Professional ethics. Deontology KW - Belgium KW - Clinical Trials as Topic KW - Randomized Controlled Trials as Topic KW - Ethics, Clinical KW - Legislation, Drug KW - Legislation, Medical KW - Biomedical Research KW - Human Experimentation KW - 34 EU KW - 351.84*7 KW - 615 <493> KW - legislation & jurisprudence. KW - organization & administration. KW - Rechtswetenschappen.--EU KW - Medisch recht. Gezondheidsrecht. Wetgeving i.v.m. ziekenhuizen KW - Farmacologie. Farmaceutische wetenschappen--België KW - Belgium. KW - 351.84*7 Medisch recht. Gezondheidsrecht. Wetgeving i.v.m. ziekenhuizen KW - 34 EU Rechtswetenschappen.--EU KW - legislation & jurisprudence KW - organization & administration 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 UR - https://www.unicat.be/uniCat?func=search&query=sysid:1504548 AB - 1: Scope of the new regulation - 2: Protection of subjects of experiments - 3: The role of the competent authority and the ethics committee(s) - 4: Procedures for conducting a clinical trial in Belgium - 5: Investigational medicinal products - 6: Special cases : non-interventional trials and non-commercial experiments - 7: Sanctions - 8: Entry into force and transition measures ER -