History of FDA and FDA Regulations
This is a course that anyone in a hospital or clinic who might be involved in conducting a clinical trial should take.
The course will take them through a history of the FDA regulations and an introduction to accessing the regulations on the FDA home page – www.FDA.gov. Many Hospitals and Clinics today are looking for ways to increase revenues. One way is for them to do more clinical trials. In order to do this they must prepare their staffs to be ready to do clinical trials. This is the first in a series of training sessions intended to do that.
Objectives of the Presentation:
History of FDA Regulations
European Regulations and Harmonization
Regulations that Apply to Clinical Research
Guidances that Apply to Clinical Research
You and the Regulations
Privacy and HIPAA
EMR – Electronic Medical Records
Who can Benefit:
Anyone who would be involved in the trial