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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

Pharmacology. Therapy --- Medical law --- Professional ethics. Deontology --- Belgium --- Clinical Trials as Topic --- Randomized Controlled Trials as Topic --- Ethics, Clinical --- Legislation, Drug --- Legislation, Medical --- Biomedical Research --- Human Experimentation --- 34 EU --- 351.84*7 --- 615 <493> --- legislation & jurisprudence. --- organization & administration. --- Rechtswetenschappen.--EU --- Medisch recht. Gezondheidsrecht. Wetgeving i.v.m. ziekenhuizen --- Farmacologie. Farmaceutische wetenschappen--België --- Belgium. --- 351.84*7 Medisch recht. Gezondheidsrecht. Wetgeving i.v.m. ziekenhuizen --- 34 EU Rechtswetenschappen.--EU --- legislation & jurisprudence --- organization & administration --- Clinical Trials as Topic - Belgium --- Randomized Controlled Trials as Topic - Belgium --- Ethics, Clinical - Belgium --- Legislation, Drug - Belgium --- Legislation, Medical - Belgium