Ken Phelps |
The special seminar will take place at noon in the College of Nursing, Room 1011/1012. Lunch will be served on a first-come, first-served basis.
The presentation will cover
- History;
- Approval pathways; and
- NDA requirements in the United States and European Union.
The discussion also will touch on the types of studies conducted at different phases, discussion of what is required at each phase and regulatory reasons.
With more than three decades of experience in the health science and services industry, Phelps is an expert in drug development and has aided in the successful FDA approval of numerous compounds.
|
Phelps began his career at the UNMC Eppley Cancer Center where he synthesized, characterized and performed drug metabolism studies of potential carcinogens. He gained early entrepreneurial experience when he established a laboratory and manufactured sterile blood collection tubes.