Biomedical Course Descriptions
Professional Writing in Science, BW701
BW701 is a foundational course that provides an introduction to 2 fundamental issues in writing and science: the rhetorical theory underlying effective communication and the social (and essentially rhetorical) context surrounding the scientific enterprise. Through discussion of these issues and practice employing them, you will be able both to identify these issues in scientific text and to orient your own writing appropriately for different audiences (mainly scientific and public).
Stylists and Editing, BW702
This course focuses on features of style that make a text
unique, taking the broadest approach to medical text in
narrative form from clinical reports to essays on medical
writing. Particular attention is paid to analyzing the style of
renowned medical writers and essayists. You will also study
modern principles of editing medical text, apply them to
sample documents, justify your choices by citing the AMA
Manual of Style, and consider the value of readability scales
and theories of grammar. Through a variety of critiques,
you will gain experience identifying advanced principles of
grammar and rhetoric while becoming aware of trends in
standards of correctness.
(Prerequisite: BW701 or permission
from the program director)
Information Strategies for Biomedical Writers, BW703
This course will enable you to identify your needs for information and sources appropriate for biomedical writing, to search a variety of databases and other Internet resources pertinent to the profession, to evaluate the information you find, and to use that information appropriately. You will also learn to retrieve information as a biomedical writer unaffiliated with a university or other library. Special attention is given to searching medical, business, and government sources likely to have statistics to use in documentation.
Regulatory Documentation Process, BW704
This course provides an understanding of clinical and nonclinical study design and regulatory reporting for biomedical products. Specific topics covered in the course include the procedures of biomedical research, standardized regulatory document formats, basic submission components, and publication requirements.
Biostatistics for Biomedical Writers, BW705
This course introduces you to 2 main aspects of the use of statistics in biomedical fields to improve your skills in reading, writing, and editing biomedical text. You will also examine the ways in which statistics support arguments in biomedical fields. The course features statistical terminology and challenges you to employ this terminology through online discussions and tests.
Ethical and Legal Issues in Biomedical Communication, BW706
This course helps you understand the important ethical and legal issues related to publishing biomedical information, including the ethics of authorship, editorship, and peer review. You will look at issues including conflicts of interest, codes of ethics, scientific misconduct, contracts, copyright, trademark, and privacy issues.
Regulatory Writing: Medical Device Submissions, BW707
The goal of this course is to teach you the process of
writing medical device submissions. Topics covered include
FDA medical device regulations, the medical device development
process, and clinical trial documents. You will
practice communicating complex scientific information in
various documents, including investigator's brochures,
clinical trial reports, and IDE/PMA/510(k) submission
components.
(Prerequisite: BW704 or permission from the
program director)
Regulatory Writing: New Drug Applications, BW708
This course emphasizes the development of clear, concise,
consistent, and complete New Drug Application (NDA)
reports, focusing on the clinical study report. It covers the
interface between clinical documents and draft package
inserts, and also evaluates the resources for preparing
clinical study reports. You will gain experience writing a
synopsis, table explanations, narrative summaries, and
labeling.
(Prerequisite: BW703, BW704, and BW705 or permission
from the program director)
Regulatory Writing: GxP Documentation, BW721
The aim of this course is to examine the process of writing
GxP documents. Topics include Good Laboratory Practices
(GLPs), Good Clinical Practices (GCPs), and Good
Manufacturing Practices (GMPs). This course will allow you
to practice communicating complex scientific information
in various GxP documents. This course builds upon the
foundation from BW704 to focus on the particular issues
unique to GxP documentation.
(Prerequisite: BW704 or
permission from the program director)
Regulatory Writing: Biologics, BW722
BW722 is an elective course. This course examines the
process of writing regulatory documentation for biologic
products. Specific topics include FDA regulation of biological
products, the biological product development process,
and clinical study documents. You will learn to communicate
complex scientific information in various documents for
biological products. This course builds upon the foundation
from BW704 and focuses on the particular issues unique
to biological products.
(Prerequisite: BW704 or permission
from the program director)
Regulatory Writing: Dietary Supplements, BW723
BW723 is an elective course. This course examines the
process of writing regulatory documentation for dietary
supplements. Topics covered include FDA and FTC regulation
of dietary supplements, as well as the FDA regulation
of food additives. You will practice communicating complex
scientific information in various documents for dietary
supplements. This course builds upon the foundation from
BW704 and focuses on the particular issues unique to
dietary supplements.
(Prerequisite: BW704 or permission
from the program director)
Anatomy and Physiology, BW731
This intensive medical science course is aimed at introducing
basic anatomy and physiology to biomedical writers with no
prior education in preclinical medical science. The goal for
this course is to teach you to become proficient in basic
anatomy and physiology, and to communicate clearly about
each system to a variety of targets using several delivery
techniques.
(Prerequisite: BW701)
Cardiovascular Disease, BW732
BW732 is an intensive biomedical science writing course
that introduces the scientific concepts on which therapies
for cardiovascular disease are based. This course examines
the processes of writing about cardiovascular disease for
both general and professional audiences, and includes
discussion of documentation of cardiovascular devices,
therapies, and clinical trials. It will also looks at published
cardiovascular research and teach you how to write such
medical documents.
(Prerequisite: BW701)
Health Articles Seminar, BW733
This intensive course requires you to read current health journal articles assigned each week and write weekly reports about such articles. The course is designed to increase your knowledge of diseases and therapeutics. It also allows you to gain facility in accessing primary and secondary sources, and to understand how to write healthcare journalism.
Continuing Medical Education, BW750
Continuing Medical Education (CME) is a growing area of specialization within biomedical writing. This course will introduce you to the concepts underlying continuing education in general and the process for developing CME courses in particular. It covers both the writing and design of effective CME programs in various media (print and digital), as well as the approval process for running such programs.
Entrepreneurship in Biomedical Communication, BW760
This course explores entrepreneurial activities in biomedical communication. You will read research literature on the evolution of the workplace and the implications of gender on the roles of consultants. You will also construct a mission statement, develop a business plan, and study legal, financial, and ethical issues of operating your own consultancy in biomedical communication.
Social History of Therapeutics (Cross-listed as HP765), BW770
This course will introduce you to the social history of selected healthcare professions and therapies. Particular attention will be paid to examples of technology in the healthcare professions (to illustrate how tools shape practice). You will also be introduced to archival documents and material culture (the study of objects, their manufacture, and use). Owing to the rich medical and pharmaceutical heritage of Philadelphia, students will visit important permanent collections at local libraries and museums.
Special Topics in Biomedical Communication, BW780
This course is intended as a forum for studying current or
innovative topics in biomedical communication. Its topic will
therefore vary from term to term. It will allow you to design
and carry out appropriate research projects keyed to the
specific topic explored in the course.
(Prerequisite: BW701)
Independent Study in Biomedical Communication, BW830
This course affords the opportunity to pursue research either
in a cognate field or on a topic not fully explored in regular
program electives. You may choose to work with a member
of the graduate faculty from another department at USP for
this study with permission of program director.
(Prerequisite:
Matriculation in the Biomedical Writing program and
BW701, BW702, and BW705)
Research in Biomedical Communication, BW860
This course introduces current research approaches-primarily
ethnographic and historical-in the field of professional
and scientific communication. It also covers the process of
publishing original research in this field. Through discussion
of representative scholarly publications, critiques of these
publications and their research design, and preparation of
a major research project, you will become more adept at
tackling various communication problems in both scholarly
and workplace writing.
(Prerequisite: Matriculation in the
Biomedical Writing Program and BW701 and BW705)
Graduate Research Project I, BW890
This course requires you to demonstrate knowledge of theory and practice in biomedical communication acquired throughout the program. A prerequisite for BW891 Graduate Research Project II, BW980 is a research-based, independent study course that allows you to develop a large project: a course for continuing medical education; a product monograph; a major research paper for publication; a website; and so on.
Graduate Research Project II, BW891
This course will require you to demonstrate knowledge of theory and practice in biomedical communication acquired throughout the program. This course is taken as a continuation of BW890 Graduate Research Project I as a research-based, independent study to further develop a large project: a course for continuing medical education; a product monograph; a major research paper for publication; a website; and so on.
Globalization and International Health, SS722
This course concerns the practice of international healthcare
within the context of globalization, which affects every
community in the world. The course also poses numerous
challenges to international health that have a direct influence
on the work of healthcare professionals in nearly every society,
including the United States. Topics span HIV outbreaks,
Mad Cow disease, SARS, and other diseases, as well as
pharmaceutical access to intellectual property rights, issues
of genetic material, and the impact of globalization on international
health. Through multidisciplinary study, you will
enhance your knowledge of the diversity of issues facing
different cultures and populations. You will also gain a specific
understanding in the social, pharmaceutical, legal, and
cultural practices affecting the solutions to these issues.
(Prerequisites: permission from instructor or PS, SO, CO, PO
or EC101)
