CTSC - Drug Development and FDA Regulations

This course provides an overview of the drug development process including Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP) processes. It is ideal for early stage investigators from varied disciplines and new industry professionals with a need to develop an understanding of the drug development process. The course will review the steps that lead up to the clinical trial process. It will discuss the phases of clinical development that are part of the IND (the actual human trials that are conducted to demonstrate safety and efficacy to allow the regulatory authorities reason to approve the investigational drug for marketing). The NDA process will then be reviewed with insight into possible post-NDA activities that may be requested. The included workbook is a great tool for reference purposes.

Learning Objectives:

1. Discuss the FDA's role in drug development

2. Explain the logic of the drug development process

3. Cite the basics of non-clinical drug testing

4. Discuss briefly the requirements for an IND

5. Cite the basics of clinical trial structure and design, including Phase 1, 2, and 3 clinical studies

6. Discuss briefly the requirements for an NDA

7. Explain briefly the post approval responsibilities of sponsors, including Phase 4 clinical studies

8. Describe the fundamentals of Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP)

Drug Development and FDA Regulations

Date: Wednesday, June 3, 2020

Time: 8:30 AM - 5:00 PM

Location: Griffis Faculty Club, 1300 York Avenue