The FDA Drug Development Process
This web presentation will provide the attendee a comprehensive overview of the FDA Drug Development Process, IND/NDA applications and GCP, GLP and GMP regulations.
Attendees will receive a foundation of knowledge about FDA's Drug Development Process, 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 presentation will enable the attendee to prepare concise documents and provide FDA required information for fast product approval.
Why Should You Attend: Professionals who require an understanding of the FDA Drug Development Process. Those professionals that require an understanding of what FDA requires relative to in-vitro, nonclinical and clinical studies. The necessary submissions required by FDA. An understanding of the entire FDA Drug Development Process is outlined for those who require this information.
Areas Covered in the Session:
Who Will Benefit:
- Understand the FDA Drug Development Process
- Learn about INDs
- Learn about NDAs
- Learn the basics for in-vitro and nonclinical testing
- Learn the basics about human clinical testing
- Learn about FDA's IND/NDA review process
- Regulatory Affairs Professionals
- Quality Professionals
- Clinical Professionals
- Research Professionals
- Manufacturing Professionals
- Other professional that require an understanding of the FDA Drug Development Process