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Pharmacoepidemiology and Drug Safety Certificate

Overview

The Certificate in Pharmacoepidemiology in 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, 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.

Eligibility

The certificate is open to currently enrolled masters, doctoral, and post-doctoral students at The Johns Hopkins University.  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 and a 2.75 or better overall GPA for certificate courses is required.  The certificate program length is flexible; it varies from student to student, however, the certificate must be completed within three years.

The student must submit a Notification of Completion to the certificate's administrative contact after completing all of the certificate 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 UnitsTerm On-CampusTerm Online
 

Introduction to Online Learning

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

0

1, 2, 3, 4,

Summer

-
550.860

Academic and Research Ethics at JHSPH

All students are required to complete this free online course during their first term of study.

0

1, 2, 3, 4,

Summer

-
Required Courses: Students must take one of the following Epidemiology series*
SeriesCourse NumberCourse NameTerm Credit UnitsTerm OnlineTerm Online
Series A

340.601Principles of Epidemiology531, S, SI
340.608Observational Epidemiology442
Series B340.751Epidemiologic Methods 15-1
340.752Epidemiologic Methods 25-2
Series C550.694Fundamentals of Epidemiology I31-
550.695Fundamental of Epidemiology II32-
340.608Observational Epidemiology442

*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 courses.

*Bloomberg degree students who earn at least a B in one introductory epidemiology (340.601 or 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

No. Credits

Online Term

Campus Term

340.645

Introduction to Clinical Trials

2

1, 3

3

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

340.682

Phamacoepidemiology: Methods and Drug Safety

2

2

3

390.631

Principles of Drug Development

1

-

2

340.684

Pharmacoepidemiology: Drug Utilization

3

-

4

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

140.633

Biostatistics in Medical Product Regulation

2

1

SI 

140.664

Causal Inference in Medicine and Public Health

43

317.600

Introduction to the Risk Sciences and Public Policy

 3

1

317.610

Risk Policy, Management and Communication

42

340.608

Observational Epidemiology

4

42

ME.330.809

Analytical Methods of Clinical Pharmacology

-

-

-

NR.110.314

Principles of Pharmacology

3

Fall, Spring

Fall, Spring

NR.110.508

Clinical Pharmacology

3

Fall, Spring

Fall, Spring

A&S

Translational Biotechnology: Licensing to Approval

3

All Terms

-

A&S 410.651

Clinical Development of Drugs and Biologics

3

All Terms

-

551.607

Pharmaceuticals Management for Under-served Populations

3

-

3

Contact Information:

Faculty Sponsor:

G. Caleb Alexander, MD, MS, Associate Professor of Medicine, Department of Epidemiology
Phone: 410-955-8168
Email: galexan9@jhmi.edu

Administrative Contact:

Frances Burman, Academic Coordinator
Department of Epidemiology
Phone: 410-955-3926

E-mail: franburman@jhu.edu

Gainful Employment Program Information

This program will be initiated in Academic Year 2014-2015; completion information will be reported after Academic Year 2015-2016.