This web seminar provides an overview of the entire FDA Drug Approval Process. This seminar will cover FDA requirements from discovery.
We will begin by developing a molecule, testing it, going through the IND process, clinical testing and finally the NDA process. We will also discuss IND/NDA submission preparation, in-vitro studies, nonclinical studies and human clinical trials. Also discussed will be the underlying scientific and regulatory principles involved in the entire Drug Development Process. This web seminar will also provide a foundation of knowledge for those who require an understanding of the entire FDA Drug Approval Process.
Areas Covered in the Session : Understand the FDA drug research requirements Learn about IND process Learn about Clinical testing requirements Learn about NDA process Learn about in-vitro and nonclinical testing
Who Will Benefit: Regulatory Affairs Personnel Quality Personnel Clinical Personnel Research Personnel Manufacturing Personnel Drug Discovery Personnel Legal Personnel Personnel who require a general understanding of the FDA Drug Approval Process