Event Detail
History of FDA and FDA Regulations
February 12, 2013 - san Francisco CA US
Online Compliance Panel
onlinecompliancepanel1@gmail.com
Phone: +1-510-857-5896
Fax: +1-510-509-9659
Description: This is a course that anyone in a hospital or clinic who might be involved in conducting a clinical trial should take. If they have never been involved they will learn what one is, if they have done clinical trials it will be useful to put everyone on the same level as far as terms and operations. 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 Nursing Staff Physicians Pharmacists Lab Technicians Finance/Accounting IT Marketing personnel