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.
Plan of Study Grid
First Year
Term 1Hours
Fall
BIOM 611 Vaccines and Immune Therapies 4
BIOM 605 Global Regulatory Requirements of Quality 3
 Hours7
Term 2
Winter
BIOM 617 Business for the Sciences 3
BIOM 629 Product Development and Validation 3
BIOM 640 Life Science Innovation I 3
 Hours9
Term 3
Spring
BIOM 635 Risk and Failure Analysis 3
BIOM 642 Life Science Innovation II 2
BIOM 643 Bioinformatics 3
 Hours8
 Total Hours24