The Declaration of Helsinki and the « new » German Drug Law of 1976 may be regarded as the first and all important step in the evolution of Good Clinical Practices (GCP) in Germany. « Regulations on the orderly conduct of clinical studies » (published in 1987), reflecting mast elements of the GCPs, caused the German industry to make provisions for more successful drug approvals in the future.
Pharmaceutical companies have improved their documentation systems with regard to study protocols and reports, increased their monitoring capacity, and began setting up SOPs.
In preparation for the issuing of the E.C. GCP guidelines companies established Clinical Quality Assurance (CQA) units responsible for various CQA task such as training of monitors and investigotors, auditing of protocols, reports, systems, and data.
Mots-clés Pascal : Industrie pharmaceutique, Technologie pharmaceutique, Législation, Recommandation, Médicament, Recherche développement, Essai clinique, Exploration clinique, Allemagne, Europe
Mots-clés Pascal anglais : Pharmaceutical industry, Pharmaceutical technology, Legislation, Recommendation, Drug, Research and development, Clinical trial, Clinical investigation, Germany, Europe
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 93-0478592
Code Inist : 002B02A03. Création : 199406.