Adverse Event Reporting and Post-Marketing Activities, BPHE 5725P
Instructor: Laurence Flint, MD, MS, MBA, RAC, FAAP
Addresses the regulations governing reporting of adverse events in clinical trials and post-marketing surveillance regulations as required by the FDA.
Required for Regulatory Affairs MS Specialization Track and Regulatory Affairs Certificate
Applied Biostatistics, BINF 5400E
Instructor: Hafiz Khan, PhD
Biostatistical theory and applications of its methods, as applied to challenging problems arising from epidemiology, environmental health, biomedical and other public health related research. This course typically consists of learning biostatistical methods and applying its methods in solving various problems using SAS software.
General Elective
Clinical Trials Overview: Methods and Practice, BPHE 5310P
Instructor: David L. Hom, MS
Basic principles of good study design and implementation.
Students learn about the phases of drug discovery from bench to market.
Required Core for all Certificates and MS
Disease Mapping & Surveillance, BINF 5006E
Instructor:
Syed S. Haque, Ph.D
Use of disease surveillance systems, geographic information systems, and various health databases to link data to public health practice and policy.
Required for Clinical Trials Management & Recruitment Science MS Track and Clinical Trial Informatics MS Track
Essentials of Health Informatics, BINF 5000E
Instructor: Shankar Srinivasan, MSc, PhD
Essentials of Health Computer Science is a developmental course in programming using the C++ language, including syntax and methodologies, program development, debugging functions, arrays structures, and pointers.
Primer for Clinical Trial Informatics MS Track-Consult Advisor
Healthcare Information Systems, BINF 5005E
Instructor: Syed S. Haque, Ph.D
Computer-based information system operation and management function in the context of various professional settings, impact of information technology on health care management are reviewed and discussed.
Required for Clinical Trial Informatics MS Specialization Track
Overview of Disease Processes and Treatment, BPHE 5510P
Instructor: Barbara Gladson, PT, OTR, PhD
Systems physiology and pathophysiology of disease and their medical treatment.
Topics covered include cardiopulmonary diseases, infectious diseases, gastroenterology, urology, endocrine and oncology. Lab and specific diagnostic tests will be reviewed.
Required for Recruitment Science Certificate and Clinical Trials Management & Recruitment Sciences MS Specialization Track
Microarrays in Clinical Trials, BINF 5225E
Instructor: Masayuki Shibata, Ph.D
An indepth introduction to the use of microarray technology, chip design, and protocol development in large-scale data collection and mining.
General Elective
Principles and Methods of Epidemiology, PHCO 0502J
Instructor: Elizabeth Marshall, PhD
This course is an introduction to the principles of epidemiology as generally used in human health research and public health disease prevention and health promotion.
Required for Clinical Trials Management & Recruitment Sciences MS Specialization Track and Elective for the Recruitment Sciences Certificate
Principles of Subject Recruitment and Retention, BPHE 6985P
Instructor: Lars-Olof Eriksson, MsSc, PhD
Training in the modern principles and techniques used in evidence-based planning of subject identification, qualification, and enrollment.
Required for Clinical Trials Management & Recruitment Sciences MS Specialization Track and Recruitment Sciences Certificate
Regulatory Requirements in Clinical Investigations, BPHE 5521P
Instructor: Madeline Ducate, MS
Foundational knowledge of regulatory guidances and requirements impacting the conduct of clinical investigations.
Required Core for all Certificates and MS
Graduate Project in Clinical Trials, BPHE 6980P
Instructor: Variable by Topic
This practicum is customized to the student’s interest in specific aspects
of clinical investigation. It is a hands-on project working with a faculty member or industry professional to help illustrate or learn a specific process by working on relevant projects.
Required Core for MS
FEATURED SPRING COURSES
Applied Clinical Trials, BPHE 6352P
Instructor: David L. Hom, MS and Rita Musanti, MSN, PhD
In-depth discussion of protocol management and patient management processes. Students are expected to apply these concepts in simulated clinical trial situations.
Required for Clinical Trials Management & Recruitment Science MS Track and Clinical Trial Informatics MS Track
Biomedical Informatics for Clinical Trials Management BINF 5075E
Instructor: Shankar Srinivasan, MSc, PhD and
Masayuki Shibata, Ph.D
Focused discussion of the principles and techniques of biomedical informatics as related to clinical trials.
Required for Clinical Trials Management & Recruitment Science MS Track and Clinical Trial Informatics MS Track
Clinical Trials Overview: Methods and Practice, BPHE 5310P
Instructor: David L. Hom, MS
Basic principles of good study design and implementation.
Required Core for all Certificates and MS
Concepts of GxPs & Quality Assurance, BPHE 6200P
Instructor: James Parmentier, PhD
A comparison of US and International requirements related to the Quality Laboratory Control, materials, production, packaging and facilities equipment systems for the production of pharmaceutical and medical device products. Review of GxPs.
Required for Regulatory Affairs MS Specialization Track and Regulatory Affairs Certificate
Cultural Diversity in Clinical Trials, BPHG 5800G
Instructors: Barbara Gladson, MS, PhD and Rita Musanti, MSN, PhD
This course promotes understanding of the effects of disparities in clinical trials and pharmacological management in global populations.
Required for Clinical Trials Management & Recruitment Science MS Track and an elective for the Recruitment Sciences Certificate
Ethical Issues in Health Care Practice, NUTR 6505E
Instructor: David M. Gibson, Ed.D., FASAHP
Bioethics, malpractice, experimentation and other critical issues are examined in a framework of multicultural diversity.
Required Core for MS
Food and Drug Law, BPHE 5110P
Instructor: Deborah Flint, MS, MBA
Historical review of events shaping food and drug law as well as an indepth exploration of current legal and regulatory requirements.
Required for Regulatory Affairs MS Specialization Track and Regulatory Affairs Certificate
Graduate Project in Clinical Trials, BPHE 6980P
Instructor: Variable by Topic
This practicum is customized to the student’s interest in specific aspects
of clinical investigation. It is a hands-on project working with a faculty member or industry professional to help illustrate or learn a specific process by working on relevant projects.
Required Core for MS
FEATURED SUMMER COURSES
Essentials of Health Informatics, BINF 5000E
Instructor: Shankar Srinivasan, MSc, PhD
Essentials of Health Computer Science is a developmental course in programming using the C++ language, including syntax and methodologies, program development, debugging functions, arrays structures, and pointers.
Primer for Clinical Trial Informatics MS Track-Consult Advisor
Healthcare Information Systems, BINF 5005E
Instructor: Syed S. Haque, Ph.D
Computer-based information system operation and management function in the context of various professional settings, impact of information technology on health care management are reviewed and discussed.
Required for Clinical Trial Informatics MS Specialization Track
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