PHARMACOEPIDEMIOLOGY AND DRUG SAFETY CERTIFICATE OVERVIEW The Certificate in Pharmacoepidemiology and Drug Safety is designed for masters and doctoral degree students enrolled at the 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 Schools of Medicine, Nursing, and Public Health, as well as School of Medicine residents and fellows engaged in outcomes and comparative effectiveness research. 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 Bloomberg School of Public Health masters, doctoral, and post-doctoral students are required to submit a short application to the Administrative Contact by September 10, 2014. Applicants are also encouraged to contact Dr. G. Caleb Alexander or Dr. Jodi Segal in order to receive advice on selecting courses. All other Johns Hopkins University masters and doctoral students must apply to the program using the school's online application before they begin taking certificate courses. The certificate application includes a CV, a statement of purpose vis-à-vis the certificate, and written approval from the student's academic advisor to pursue the certificate. The application does not require scores from the GRE, TOEFL, or ILETS. The certificate program will review the applications and notify each applicant of its admissions decision. Only those approved and notified by the certificate admissions committee may earn the certificate.
In the "Academic Program" module of the application, you will be asked to choose the degree program you are applying for. If you are a degree seeking student in another Johns Hopkins University school (i.e. School of Medicine, School of Nursing, Carey Business School, etc) please choose the option that says Certificate_for Credit-Hopkins Degree student. Non-JHU applicants (applicants who are not currently enrolled in a degree program at the Johns Hopkins University) must also apply using the school s online application before they begin taking certificate courses. The certificate application includes official transcripts from all postsecondary schools, a CV, a statement of purpose vis-à-vis the certificate, one letter of recommendation, and written approval from the student's academic advisor to pursue the certificate. Transcripts from non-us institutions must be approved by a credentialing agency. The application does not require GRE scores. Applicants from countries where English is not the official language must submit scores of an English Language Proficiency test (TOEFL or ILETS). Please visit the JHSPH Admissions Website for more information on who is required to submit these scores. The certificate program will review the applications and notify each applicant of its admissions decision. Only those approved by the certificate admissions committee may earn the certificate. In the "Academic Program" module of the application, you will be asked to choose the degree program you are applying for. If you are not a degree seeking student within Johns Hopkins University, please choose the option for Certificate_for Credit-Non Degree Student. APPLICATION DEADLINE Applications for the Certificate in Pharmacoepidemiology are reviewed on a rolling basis; however, applications must be received at two academic quarters before the expected graduation date. COURSE OF STUDY Academic/Curriculum Requirements for Successful Completion The Certificate in Pharmacoepidemiology and Drug Safety requires at least 20 term credit units in total and consists of required and core courses in pharmacoepidemiology, principles and drug development, and elective courses focusing on additional regulatory, clinical, and research topics relevant to the field. The courses are taught by faculty from the Johns Hopkins Bloomberg School of Public Health and the Krieger School of Arts and Sciences on the East Baltimore or Homewood campuses and/or online. Required Courses: Students must take one of the following two-course Epidemiology series* Series Course Number Course Name On-campus Online Credit Units Series A Series B 340.601 Principles of Epidemiology 1, Summer,** Summer Inst. -- 5 340.608 Observational Epidemiology 2, Summer Inst. 3 4 340.751 Epidemiologic Methods 1 1 -- 5 340.752 Epidemiologic Methods 2 2 -- 5
Series C 550.694 Fundamentals of Epidemiology I 550.695 Fundamentals of Epidemiology II -- 1 3 -- 2 3 340.608 Observational Epidemiology 2, Summer Inst. 3 4 *Non-degree students may waive the two-course 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 two-course 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 degree students during the Summer Institute. Required Courses: Students must also take the following course Course Number Course Name Oncampus Online Credits 340.645 Introduction to Clinical Trials 2 1 3 Core Courses: Students must take at least 2 of the following 3 courses Number Course oncampus online Credits 340.682 Pharmacoepidemiology: Methods and Drug Safety 2 -- 3 390.631 Principles of Drug Development 1 -- 2 Under JHSPH development Pharmacoepidemiology: Utilization 3 Elective Courses: Students complete the 20 term credit requirement through the following
oncampus online Credits 140.633 Biostatistics in Medical Product Regulation Summer Inst 1 2 140.664 Causal inference in Medicine and Public Health 3 -- 4 317.600 Introduction to the Risk Sciences and Public Policy 1 3 317.610 Risk Policy, Management and Communication 4 3 340.608 Observational Epidemiology 2, Summer Inst. 3 4 ME.330.809 Analytical Methods of Clinical Pharmacology -- -- -- NR.110.314 Principles of Pharmacology Fall, Spring Fall, Spring 3 NR.110.508 Clinical Pharmacology Fall, Spring Spring 3 A&S 410.627 Translational Biotechnology: Licensing to Approval -- All terms 3 A&S 410.651 Clinical Development of Drugs and Biologics -- All terms 3 Requirements for Successful Completion All required and elective courses must be taken for a letter grade and a 3.0 or better overall GPA for all certificate courses is required. Requirements must be completed within a three-year period. 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. CONTACT INFORMATION: Faculty Sponsor: G. Caleb Alexander, MD, MS, Associate Professor of Medicine, Department of Epidemiology Phone: 410 955 8168; Email: galexand@jhsph.edu Administrative Contact Frances Berman, Academic Coordinator Department of Epidemiology Phone: 410 955 3926; Email: fburman@jhsph.edu 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 disclosure. This program will be initiated in Academic Year 2014-2015; completion information will be reported after Academic Year 2015-2016.