Shire velaglucerase alfa program included the largest and most comprehensive set of Phase III clinical trials conducted to date for Gaucher disease. About 100 patients at 24 sites in 10 countries around the world have participated in the clinical trials.
Each course is taught by instructors with personal experience conducting FDA inspections and being quality system consultant for industry. As a result, participants will receive practical guidance from those who understand the expectations of FDA inspectors and resource realities faced regulated industry.ICGC member states are planning in order accept common standards for informed consent and ethical oversight. While compliance will be after for each member state the demands, be consortium develop policies in that cancer patient have a ICGC – related degree stating that her Attendance is voluntary, that their clinical care by their participation by their participation and that data will from research with her specimens obtained provided to the international research community. ICGC members of should also take measures in order to ensure that all the samples be encoded and in a manner treatments and are stored to protect the identity of the participants in the study.