Choose an application

• Reference Manager
• EndNote
• RefWorks (Direct export to RefWorks)

Deontologie --- Déontologie --- Geneesmiddelen --- Médicaments --- Pharmacie --- Legislation, Drug --- Legislation, Drug - Belgium

Choose an application

• Reference Manager
• EndNote
• RefWorks (Direct export to RefWorks)

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