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Pharmacoepidemiology and Drug Safety Certificate


The Certificate in Pharmacoepidemiology and Drug Safety is designed for masters and doctoral degree students enrolled at Johns Hopkins Bloomberg School of Public Health and in other Johns Hopkins University divisions, including the Schools of Medicine and Nursing and the Krieger School of Arts and Sciences. It is also designed for early and mid-career public health professionals who wish to expand their knowledge of pharmacoepidemiology and drug safety to inform their work in academic, regulatory, or industry settings.

Educational Objectives

This certificate program will provide learners with core knowledge of pharmacoepidemiology and drug safety, as well as insights from these fields that can inform the work of policy-makers, patients, clinicians and payers seeking to improve the quality and safety of medication use. Upon completion of the core courses required for the Pharmacoepidemiology certificate program, participants will have the ability to:

  1. Identify the processes of drug development;
  2. Explain key requirements in biomedical product regulation and their rationale;
  3. Participate in the design of studies, both observational and experimental, to assess the effectiveness of drugs;
  4. Employ techniques to study the patterns and determinants of drug utilization;
  5. Apply approaches to examine drug safety as well as the detection of adverse drug events.


The certificate program is open to currently enrolled masters and doctoral students at The Johns Hopkins University, with the exception of JHSPH MAS students, who are not eligible to apply until they have completed their primary degree program. It is also offered to non-degree students with at least a baccalaureate degree from an accredited college or university, a strong record of successful academic performance, and a minimum of three years (full-time equivalent) of professional experience in a related health care field.

Admissions Process

Applicants should review the How to Apply page for information about eligibility and special instructions.

The certificate program review committee will review the applications and notify each applicant of their admissions decision. Only those approved by the certificate admissions committee may earn the certificate.

Requirements for Successful Completion

The certificate requires a minimum of 20 term credits. All required and elective courses must be taken for a letter grade; a minimum grade of C is required in all certificate coursework and students must maintain a 2.75 or better overall GPA for all certificate coursework. 

 The certificate program length is flexible; it varies from student to student, however, the certificate must be completed within three years.

The student should review the section of the website that addresses completion before completing certificate program requirements. The student's transcript will not indicate that the certificate was earned until the Notification of Completion has been submitted, verified by the certificate program, and processed by the Registrar.

Course of Study

Students should check the course catalog to confirm when courses are offered. The term and time may change from what is listed in the table below and students should also check for pre-requisites and whether instructor consent is required.

Course NumberCourse NameTerm Credit Units Campus TermCampus Term 

Introduction to Online Learning

All students are required to complete this free course before taking other online courses.


1, 2, 3, 4,



Academic and Research Ethics at JHSPH

All students taking the certificate for academic credit are required to complete this free online course during their first term of study.


1, 2, 3, 4,


Required Courses: Students must take one of the following Epidemiology series*
SeriesCourse NumberCourse NameTerm Credit UnitsTerm OnlineCampus Term 
In Series A, students may choose between either 340.601 or 340.721.  They must also complete 340.722
Series A

340.601Principles of Epidemiology5-S, SI
340.721Epidemiologic Inference in Public Health I53, SI1
340.722Epidemiologic Inference in Public Health II422
Series B340.751Epidemiologic Methods 15-1
340.752Epidemiologic Methods 25-2

*Non-degree students may waive the Epidemiology series by providing a transcript from another institution demonstrating successful completion of at least one graduate level course in epidemiology and one in biostatistics. These students must still complete at least a total of 20 term credits of required, core, and elective certificate program courses.

*Bloomberg degree students who earn at least a B in one introductory epidemiology (340.601, 340.721 or 340.751) and one introductory biostatistics course (140.611, 621, 651, or 751) may use these courses to fulfill the Epidemiology series requirement.

**Principles of Epidemiology is offered only to full-time MPH students during the summer term (July-August), but is available to non-Bloomberg students during the Summer Institute.

Required Courses: Students must also take the following course:

Course Number

Course Name

Term Credit Units

Term Online

Campus Term


Introduction to Clinical Trials




Core Courses: Students must take at least 2 of the following 3 courses:


Pharmacoepidemiology Methods 




340.684Pharmacoepidemiology: Drug Utilization
(course alternates between online and on-campus annually)


Principles of Drug Development




Elective Courses: Students complete the 20 term credit requirement through the following:


Biostatistics in Medical Product Regulation (on hiatus)





Causal Inference in Medicine and Public Health

140.665Causal Inference in Medicine and Public Health II3-4
221.610Pharmaceuticals Management for Underserved Populations3-3
308.630U.S. Pharmaceutical Policy3-4


Introduction to the Risk Sciences and Public Policy




Risk Policy, Management and Communication



(NB: this course is only appropriate for the certificate program if 340.682 Pharmacoepidemiology Methods was not taken)



Epidemiologic Inference in Public Health II




Clinical Pharmacology*





Translational Biotechnology: Licensing to Approval*


All Terms


A&S 410.651

Clinical Development of Drugs and Biologics*


All Terms


*Courses are not taught at the Bloomberg School; please refer to the appropriate school's course catalog for information about availability and pre-requisite course requirements.

NR: Course is taught by faculty from the JHU School of Nursing on the East Baltimore campus.
A&S: Courses are taught by faculty from the JHU Krieger School of Arts and Sciences Advanced Academic Programs.

Contact Information

Certificate Program Contact
Name: Sheila Small


Faculty Sponsor
G. Caleb Alexander, MD, MS

Jodi Segal, MD MPH

Gainful Employment Program Information

In accordance with US Department of Education regulations, the JHU Bloomberg School of Public Health is required to disclose graduation rate data, median loan debt data, and other select information for all Title IV eligible gainful employment programs. To see the most recent data available for this gainful employment program, please view the attached disclosure.