The research centre works in strict accordance with the actual laws and directives on the performance of studies like the "Act on drugs and medical device" (AMG/MPG, German: Arzneimittel- und Medizinproduktegesetz), the "Good Clinical Practice (ICH/GCP)", the "Declaration of Helsinki", a Declaration of the World Medical Association (WMA) about ethic principles for medical research on humans, and according to the DIN EN ISO 9001:2008 (quality management).
The German Medicines Act (AMG) controls an appropriate supply of medical products to humans and animals, safety in the use of drugs and ensures the quality, efficacy and harmlessness of the medication. (source: AMG § 1)
The Medical Devices Act (MPG) controls the handling of medical devices and thereby ensures safety, adequacy and efficiency of the devices as well as the health and the required protection of the patients, operator and third persons. (source: MPG § 2)
So far we have performed more than 40 clinical studies (phase II to IV). The following diagram describes the different study phases:
|Phase I||Phase II||Phase III||Approval||Phase IV|
|Small number of healthy subjects||Small number of patients||Large number of patients||Monitoring after approval, risk-benefit assessment, recommendation for the dosage|