Translational Life Sciences
Upon completion of the Translational Life Sciences Concentration, the student will be able to:
- identify risks and design process controls to reduce risk to product quality.
- determine the correct classification of medical devices in order to design an appropriate development strategy.
- identify primary and secondary clinical trial targets to demonstrate product safety and efficacy.
- describe the medical device and pharmaceutical Quality Systems, and how those systems enable organizations to consistently produce products that are of the purported quality and safety, and meet user needs.
- describe what needs to be studied and demonstrated during medical device and drug product development.
- determine effective ways to monitor and predict product process performance.
- demonstrate practical use of risk management tool.
| First Year | ||
|---|---|---|
| Term 1 | Hours | |
| Fall | ||
| BIOM 611 | Vaccines and Immune Therapies | 4 |
| BIOM 605 | Global Regulatory Requirements of Quality | 3 |
| Hours | 7 | |
| Term 2 | ||
| Spring | ||
| BIOM 617 | Business for the Sciences | 3 |
| BIOM 629 | Product Development and Validation | 3 |
| BIOM 640 | Life Science Innovation I | 3 |
| Hours | 9 | |
| Term 3 | ||
| Summer | ||
| BIOM 635 | Risk and Failure Analysis | 3 |
| BIOM 642 | Life Science Innovation II | 2 |
| BIOM 643 | Bioinformatics | 3 |
| Hours | 8 | |
| Total Hours | 24 | |