Pharmacology 620

Introduction to Regulatory Science

Fall Semester

Room: Pharm Library (NE401 Med/Dent) 

Wednesdays 6:00 - 7:00 

Directors:  Ken Dretchen & Erin Wilhelm 

Regulatory science is an applied scientific discipline that generates and makes use of evidence-based knowledge to inform decision-making about the safety and benefits of medical products. This survey course will examine the myriad issues that arise in the field of regulatory science, and will introduce students to fundamental principles of regulatory science, describe the differences between regulatory science and regulatory affairs, and provide an overview of the innovative clinical research tools of regulatory science. Building upon the Strategic Plan of The Food and Drug Administration (FDA): Advancing Regulatory Science at FDA (August 2011), individual classes will focus on the eight priority areas defined by the FDA as necessary for advancing regulatory science. Expert lecturers from Georgetown University and the FDA will present case studies, best practice examples, and guide discussion of key issues.

Syllabus

COURSE TOPICS 
  • Fundamentals of Regulatory Science 
  • Regulatory Affairs and the Law 
  • Regulatory Science and Bioethics 
  • Clinical Research Tools of Regulatory Science 
  • Novel Technologies for Innovative Medical Products 
  • Bioinformatics 
  • Personalized Medicine and Patient-Reported Outcomes
  • Biosurveillance, Medical Countermeasures, and Global Health
  • Product Manufacuring and Quality 
  • Toxicology and Product Safety 
  • Regulatory Science and Social and Behavioral Sciences 
  • Regulatory Science and Food Safety
  • Regulatory Science and Tobacco Products 
  • Conclusions and Review