PHAR-620 Introduction to Regulatory Science
Fall for 2017-2018
No faculty information available
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 Food and Drug Administration’s (FDA) Strategic Plan: 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.

EIGHT PRIORITY ISSUES DEFINED BY THE FDA
1. Modernize Toxicology to Enhance Product Safety
2. Stimulate Innovation in Clinical Evaluations and Personalized Medicine to Improve Product Development and Patient Outcomes
3. Support New Approaches to Improve Product Manufacturing and Quality
4. Ensure FDA Readiness to Evaluate Innovative Emerging Technologies
5. Harness Diverse Data through Information Sciences to Improve Health Outcomes
6. Implement a New Prevention-Focused Food Safety System to Protect Public Health
7. Facilitate Development of Medical Countermeasures to Protect Against Threats to U.S. and Global Health and Security
8. Strengthen Social and Behavioral Science to Help Consumers and Professionals Make Informed Decisions about Regulated Products

COURSE TOPICS
1. Fundamentals of Regulatory Science
2. Regulatory Affairs and the Law
3. Regulatory Science and Bioethics
4. Clinical Research Tools of Regulatory Science
5. Toxicology and Product Safety
6. Personalized Medicine and Patient-Reported Outcomes
7. Product Manufacturing and Quality
8. Genetics and Product Development
9. Novel Technologies for Innovative Medical Products
10. Bioinformatics
11. Food Safety
12. Biosurveillance, Medical Countermeasures, and Global Health (Part I)
13. Biosurveillance, Medical Countermeasures, and Global Health (Part II)

Meets Weds 6:00-8:00
Credits: 2
Prerequisites: None
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