Although the proposed Certificate in Pharmacoepidemiology and Drug Safety remains under administrative review, there are many relevant courses offered at Johns Hopkins that can be pursued at the present time.
Principles of Epidemiology (340.601)
Introduces principles and methods of epidemiologic investigation of infectious and noninfectious diseases. Illustrates methods by which studies of the distribution and dynamic behavior of disease in a population can contribute to an understanding of etiologic factors, modes of transmission, and pathogenesis. Presents different types of study design, including randomized trials, case-control and cohort studies, risk estimation and causal inferences. Demonstrates the relationship between epidemiology and the development of policy. Laboratory problems provide experience in epidemiologic methods and inferences, illustrating a common-vehicle epidemic; the spread of infectious disease in school, home, and community; epidemiological aspects of a noninfectious disease; vaccination; the epidemiological approach to health services evaluation; rates of morbidity and mortality; sensitivity and specificity; and life table methods. No auditors permitted.
Observational Epidemiology (340.608)
Expands upon material presented in Principles of Epidemiology (340.601) and provides opportunity to learn more about epidemiologic concepts as applied to cohort and case-control studies. Emphasizes interpretation and the ability to critically evaluate observational study designs and methods of data analysis. Intermediate concepts include measures of association, bias, confounding, and interaction/effect modification, and are illustrated in the context of analytic observational study designs.
Pharmacoepidemiology Methods (340.682)
Acquaints students with the key elements of pharmacoepidemiology. Explores the utilization and effects of drugs in large numbers of people. Discusses the application of epidemiological methods to pharmacological issues. Focuses heavily on questions of pharmacodynamics, concentrating on clinical patient outcomes and on therapeutics (i.e., appropriate use of drugs). Applies the research methods of clinical epidemiology (e.g., randomized trials, cohort studies, case-control studies) to the content area of pharmacology (e.g., determinants of beneficial and adverse drug effects, effects of genetic variation on drug effect, dose-response relationships, duration-response relationships, clinical effects of potential drug-drug interactions, effects of non-adherence). Examines programmatic efforts to improve medication use on a population basis.
Pharmacoepidemiology: Drug Utilization (340.684)
Presents students with drug classification systems, and reviews data sources used for drug utilization research; ranging from primary data collection using surveys and audits of patients and providers to secondary data from administrative claims, electronic health information, and other sources. Reviews methods used to examine drug utilization and to evaluate interventions to modify utilization, such as time-series designs and segmented regression analyses. Considers varied patient, provider, practice and system-level determinants of prescription drug utilization, including their impact on costs and quality of care. Emphasizes the impact of drug formularies, marketing and promotion and emerging evidence of benefits and harms. Also covers topical areas such as adherence and value-based insurance designs, as well as the utilization of complementary and alternative medicines.
Principles of Drug Development (390.631)
Presents principles underlying preclinical and clinical development of new therapeutic drugs, devices, and diagnostic tests. Describes and evaluates specific examples, and discusses legal and ethical regulations that apply to drug development. Uses a case-based class format.
Biostatistics in Medical Product Regulation (140.633)
Provides a broad understanding of the application of biostatistics in a regulatory context. Reviews the relevant regulations and guidance documents. Includes topics such as basic study design, target population, comparison groups, and endpoints. Addresses analysis issues with emphasis on the regulatory aspects, including issues of missing data and informative censoring. Discusses safety monitoring, interim analysis and early termination of trials with a focus on regulatory implications.
Causal Inference in Medicine and Public Health (140.664)
Presents an overview of methods for estimating causal effects: how to answer the question of "What is the effect of A on B?" Includes discussion of randomized designs, but with more emphasis on alternative designs for when randomization is infeasible: matching methods, propensity scores, regression discontinuity, and instrumental variables. Methods are motivated by examples from the health sciences, particularly mental health and community or school-level interventions.
Introduction to the Risk Sciences and Public Policy (317.600)
Provides an introduction to the basic paradigm for quantitative risk assessment and illustrates its application in the public policy process using case studies. Examines risk assessment in a broad societal context, considering social, economic, and political factors that affect risk decision-making; evolution of risk assessment; and the use of risk assessment in regulatory processes. Students complete a risk assessment exercise.
Risk Policy, Management, and Communication (317.610)
Provides students with an understanding of how the risk sciences are applied in the formulation and implementation of public health policy in "the real world." Utilizes a case-study approach in placing science-based risk assessment into broad societal context, which includes consideration of social, economic, and political factors that affect decisions regarding risk policy and management. In addition, students gain an overview of public policy development theory, risk management tools and the application of risk communication principles.
Social Ecological Approaches to Health Regimen Adherence in Chronic Conditions (410.680)
Addresses social approaches to promoting sustained adherence to health regimens among persons living with chronic conditions. Addresses prescribed use of medications, lifestyle changes, and retention in healthcare over time among persons living with HIV/AIDS, hypertension, and other chronic conditions. Enables students to: (1) assess adherence to health regimens, (2) identify correlates of adherence at the individual, interpersonal, and social network levels, and (3) assess major approaches and components of medical adherence interventions, and their linkage to theories of behavior change. Explores social factors impacting vulnerable populations' medical adherence and health disparities, drawing examples from both domestic and international contexts.
Pharmaceuticals Management for Underserved Populations (551.607)
Students analyze problems and develop strategies based on real world drug management issues, including regulations, manufacture, procurement, distribution, safety, policy, financing and the unique aspects of international pharmaceutical trade, the role of the World Trade Organization -- Trade-Related Aspects of Intellectual Property Rights (WTO-TRIPS), government, NGOs and individuals in the selection and use of pharmaceutical products. Course materials are drawn from both developed and developing countries so that the student will be knowledgeable about the role of Essential Medicines and the formation of a National Drug Policy. Uses a multidisciplinary approach to provide students with an operational understanding of factors influencing access to and use of pharmaceuticals and other health commodities. Collectively, these materials and approaches are intended to stimulate critical thinking on how to improve access to and the use of pharmaceutical products.
Clinical Pharmacology (School of Medicine.330.809)
Prerequisite: Permission of the instructor. A series of sixteen intensive one and one half hour small group session covering fundamental methods for compartmental and non-compartmental analysis of pharmacokinetic and pharmacodynamic data. Each topic is introduced with a teach-do-review sequence focusing on skill building exercises. Introduction to pharmacokinetic data analysis using Pharsight's WinNonlin software. Required course for Clinical Pharmacology fellows.
Clinical Pharmacology (School of Nursing.110.508)
This course focuses on the clinical uses and mechanisms of action of drug groups used in altered states of physiological function. Pharmacological mechanisms, drug interactions, side effects and contraindications will be presented as bases for clinical judgment and management of patients.
Translational Biotechnology: From Intellectual Property to Licensing (Krieger School of Arts and Sciences 410.627)
This course provides an extensive overview of a process for development of a pharmaceutical by a biotechnology company or pharmaceutical company. The course emphasizes the importance of intellectual property, the basic sciences underpinning the development of a product, and the importance of the interaction between a company and the Food and Drug Administration (FDA). Students learn to appreciate the importance of quality control and assurance, good manufacturing practices, preclinical and clinical testing, and the lengthy regulatory processes which govern the development, manufacture, and eventual sale of biotechnological products. Hands-on solving of practical problems and guest lecturers who are experts in the field familiarize students with the intricacies of the process. Prerequisites: 410.303 Foundations of Bioscience, OR 410.601 Biochemistry and 410.603 Advanced Cell Biology or admission to the MS in Regulatory Science or the Masters in Biotechnology Enterprise and Entrepreneurship.
Clinical Development of Drugs and Biologics (Krieger School of Arts and Sciences 410.651)
This course introduces students to the planning and work required to develop potential new drugs and biologics efficiently. Students gain a thorough appreciation of FDA and ICH regulations and guidelines. Because the course emphasizes the importance of planning before the execution of any of the necessary steps, lectures use a "backwards" approach, discussing the final analysis and report before developing protocols. Topics also include an overview of preclinical investigations; NDA/BLA format and content; clinical development plans; product and assay development; the IND; and trial design, implementation, and management. Prerequisites: 410.601 Biochemistry; 410.602 Molecular Biology or admission to the MS in Bioscience in Regulatory Affairs Program