Course Learning Objectives
Upon successfully completing this course, students will be able to:
- Describe the process of drug development in the United States and articulate the criteria for marketing approval
- Explain the concept of risk management and distinguish among the different levels and types of programs
- Evaluate the quality and limitations of a Pharmacoepidemiology study design by applying concepts unique to pharmaceutical exposures
Course DescriptionIntroduces students to pharmacoepidemiology, application of epidemiologic methods to study uses and effects of pharmaceutical products in human populations. In addition to the identification and quantification of new adverse events and risk factors, students also examine studies of disease natural history necessary to understand drug effects and studies of drug utilization. Covers the development up to and including the seminal Phase 3 clinical trials for approval, the regulatory process, and the use and design of Risk Evaluation and Management (REMS) programs to mitigate known risks; identification of new risks for marketed products, including both active and passive surveillance programs, and the application of data mining; databases and study designs used in pharmacoepidemiology; the decision-making process in pharmacoepidemiology using contemporary examples; and new and emerging developments in the field including the application of meta-analysis to answer safety questions, the saf
Intended AudienceJHSPH students and Summer Institute participants.
Methods of Assessment
Additional Faculty Notes:
Grading: The grades will be based on class participation (10%) and a take-home Final Exam (90%).
The final exam will be passed out in class on Friday June 21st (and posted on CoursePlus) and is due on Monday July 8 at 10pm EST. It is an “open book” exam. Be sure to reference source material.
Additional Faculty Notes:
Pharmacoepidemiology, 4th Edition
Brian L Strom (Editor)ISBN: 978-0-470-86681-8Hardcover910 pageshttp://www.wiley.com/WileyCDA/WileyTitle/productCd-0470866810,descCd-tableOfContents.html
Please see the course Session for a full list of dates and items for this course.
Academic Ethics Code
Students enrolled in the Bloomberg School of Public Health of The Johns Hopkins University assume an obligation to conduct themselves in a manner appropriate to the University's mission as an institution of higher education. A student is obligated to refrain from acts which he or she knows, or under the circumstances has reason to know, impair the academic integrity of the University. Violations of academic integrity include, but are not limited to: cheating; plagiarism; knowingly furnishing false information to any agent of the University for inclusion in the academic record; violation of the rights and welfare of animal or human subjects in research; and misconduct as a member of either School or University committees or recognized groups or organizations.
Kevin Fain, JD, MPH
G Caleb Alexander, MD, MS
Disability Support ServicesIf you are a student with a documented disability who requires an academic accommodation, please contact Betty H. Addison in the Office of Student Life Services: firstname.lastname@example.org, 410-955-3034, or 2017 E. Monument Street.