This session will address the basic Drug Development Process, nonclinical trials and human clinical trials. In addition the two major FDA submissions during Drug Development will be covered - the IND submission and the NDA submission.
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The FDA Drug Development Process
This webinar provides an overview of the FDA's Drug Development Process. This webinar also includes the major FDA regulations involved in the Drug Development Process - the GLP, GMP and GCP regulations.
This webinar is ideal for those who are new to the Drug Development process and those experienced researchers that need an update on FDA requirements.
Why should you Attend: This webinar is a must for those who have to have an understanding of FDA's Drug Development Process.
Areas Covered in the Session:
Who Will Benefit:
- Overview of FDA's Drug Development Process
- Nonclinical studies required
- Human clinical studies required
- IND requirements
- NDA requirements
- Regulatory Affairs Personnel
- Quality Personnel
- Research Personnel
- Clinical Personnel
- Project Managers
- Legal Personnel
- Those personnel that require a general understanding of the FDA's Drug Development Process