Drug Development and Pharmacoepidemiology

Pharmacoepidemiology is a scientific discipline that uses epidemiological methods to evaluate the use, benefits and risks of drugs, devices and biologicals. It focuses on observational research methods that use data which are generated in the usual care of patients. This four-course specialization teaches: The drug development process Methods for assessing use of products with real-world data Observational methods for effectiveness evaluation Methods for pharmacovigilance and safety evaluation The course directors provide insights from the field to inform trainees and professionals seeking to improve the quality and safety of medication use. This course is ideally suited for early and mid-career medicine, pharmacy, and public health professionals who wish to expand their knowledge of pharmacoepidemiology and drug safety to inform their work in academic, regulatory, or industry settings

• Articulate principles and methods to quantify drug use, safety, and effectiveness post-market
• Contribute to and critically assess study designs on drug utilization and safety
• Understand challenges in optimizing pharmacotherapy value and stakeholder roles

• Basic familiarity with relevant terminology
• Readiness to engage in applied exercises or case studies