Coursework Artinya Fluorescent

Online Courses

410.302.81 - Bio-Organic Chemistry

$4322

Kenneth Thompson

Online 5/30 - 8/22

This course provides a foundation in structural organic chemistry, acid base chemistry, chemical thermodynamics, and reaction mechanisms. Subjects include Lewis structures, atomic and hybridized orbitals, stereochemistry, inter- and intramolecular forces of attraction, neucleophilic reaction mechanisms, functional groups, and the organic chemistry of biological molecules. Please note that this course does not count toward requirements for the master’s degree in biotechnology. Prerequisite: two semesters of college chemistry.

Technology Fee: $175.00

410.303.81 - Foundations in Bioscience

$4322

Weiying Pan

Online 5/30 - 8/22

This course examines the fundamental underlying scientific concepts utilized in the creation and development of biomedical products. Topics to be covered include the structure and function of biomolecules, such as proteins, enzymes, carbohydrates, lipids, and DNA, as well as the structure and function of cellular components, such as membranes, vesicles, organelles, and the cytoskeleton. In addition, students will examine the complexities of metabolism, DNA replication, transcription, translation, signal transduction mechanisms, apoptosis, the cell cycle, and cancer. Please note that this course does not count toward requirements for the master’s degree in either biotechnology or regulatory science and is required as a prerequisite course for some students entering the Master of Science in Regulatory Science.

Technology Fee: $175.00

410.601.81 - Biochemistry

$4322

Karen Wells

Online 5/30 - 8/22

This course explores the roles of essential biological molecules focusing on protein chemistry, while covering lipids and carbohydrates. It provides a systematic and methodical application of general and organic chemistry principles. Students examine the structure of proteins, their function, their binding to other molecules, and the methodologies for the purification and characterization of proteins. Enzymes and their kinetics and mechanisms are covered in detail. Metabolic pathways are examined from thermodynamic and regulatory perspectives. This course provides the linkage between the inanimate world chemistry and the living world of biology.

Technology Fee: $175.00

410.601.82 - Biochemistry

$4322

Satarupa Das

Online 5/30 - 8/22

This course explores the roles of essential biological molecules focusing on protein chemistry, while covering lipids and carbohydrates. It provides a systematic and methodical application of general and organic chemistry principles. Students examine the structure of proteins, their function, their binding to other molecules, and the methodologies for the purification and characterization of proteins. Enzymes and their kinetics and mechanisms are covered in detail. Metabolic pathways are examined from thermodynamic and regulatory perspectives. This course provides the linkage between the inanimate world chemistry and the living world of biology.

Technology Fee: $175.00

410.601.83 - Biochemistry

$4322

Satarupa Das

Online 5/30 - 8/22

This course explores the roles of essential biological molecules focusing on protein chemistry, while covering lipids and carbohydrates. It provides a systematic and methodical application of general and organic chemistry principles. Students examine the structure of proteins, their function, their binding to other molecules, and the methodologies for the purification and characterization of proteins. Enzymes and their kinetics and mechanisms are covered in detail. Metabolic pathways are examined from thermodynamic and regulatory perspectives. This course provides the linkage between the inanimate world chemistry and the living world of biology.

Technology Fee: $175.00

410.601.84 - Biochemistry

$4322

Online 5/30 - 8/22

This course explores the roles of essential biological molecules focusing on protein chemistry, while covering lipids and carbohydrates. It provides a systematic and methodical application of general and organic chemistry principles. Students examine the structure of proteins, their function, their binding to other molecules, and the methodologies for the purification and characterization of proteins. Enzymes and their kinetics and mechanisms are covered in detail. Metabolic pathways are examined from thermodynamic and regulatory perspectives. This course provides the linkage between the inanimate world chemistry and the living world of biology.

Technology Fee: $175.00

410.602.81 - Molecular Biology

$4322

Valerie Divito

Online 5/30 - 8/22

This course provides a comprehensive overview of the key concepts in molecular biology. Topics to be covered include nucleic acid structure and function, DNA replication, transcription, translation, chromosome structure, and remodeling and regulation of gene expression in prokaryotes and eukaryotes. Extended topics to be covered include method in recombinant DNA technology, microarrays, and microRNA.

Technology Fee: $175.00

410.602.82 - Molecular Biology

$4322

Robert Webb

Online 5/30 - 8/22

This course provides a comprehensive overview of the key concepts in molecular biology. Topics to be covered include nucleic acid structure and function, DNA replication, transcription, translation, chromosome structure, and remodeling and regulation of gene expression in prokaryotes and eukaryotes. Extended topics to be covered include method in recombinant DNA technology, microarrays, and microRNA.

Technology Fee: $175.00

410.602.83 - Molecular Biology

$4322

Roza Selimyan

Online 5/30 - 8/22

This course provides a comprehensive overview of the key concepts in molecular biology. Topics to be covered include nucleic acid structure and function, DNA replication, transcription, translation, chromosome structure, and remodeling and regulation of gene expression in prokaryotes and eukaryotes. Extended topics to be covered include method in recombinant DNA technology, microarrays, and microRNA.

Technology Fee: $175.00

410.602.84 - Molecular Biology

$4322

Dr. Mark Hollier

Online 5/30 - 8/22

This course provides a comprehensive overview of the key concepts in molecular biology. Topics to be covered include nucleic acid structure and function, DNA replication, transcription, translation, chromosome structure, and remodeling and regulation of gene expression in prokaryotes and eukaryotes. Extended topics to be covered include method in recombinant DNA technology, microarrays, and microRNA.

Technology Fee: $175.00

410.603.81 - Advanced Cell Biology I

$4322

Laundette Jones

Online 5/30 - 8/22

This course covers cell organization and subcellular structure Students examine the evolution of the cell, chromosome, and plasma membrane structures and behaviors; mechanics of cell division; sites of macromolecular synthesis and processing; transport across cell membranes; cell dynamics; organelle biogenesis; and cell specialization. Students are also introduced to the experimental techniques used in cell biology to study cell growth, manipulation, and evaluation.

Technology Fee: $175.00

410.603.82 - Advanced Cell Biology I

$4322

Mark Verdecia

Online 5/30 - 8/22

This course covers cell organization and subcellular structure Students examine the evolution of the cell, chromosome, and plasma membrane structures and behaviors; mechanics of cell division; sites of macromolecular synthesis and processing; transport across cell membranes; cell dynamics; organelle biogenesis; and cell specialization. Students are also introduced to the experimental techniques used in cell biology to study cell growth, manipulation, and evaluation.

Technology Fee: $175.00

410.603.83 - Advanced Cell Biology I

$4322

Jeffrey Mahr

Online 5/30 - 8/22

This course covers cell organization and subcellular structure Students examine the evolution of the cell, chromosome, and plasma membrane structures and behaviors; mechanics of cell division; sites of macromolecular synthesis and processing; transport across cell membranes; cell dynamics; organelle biogenesis; and cell specialization. Students are also introduced to the experimental techniques used in cell biology to study cell growth, manipulation, and evaluation.

Technology Fee: $175.00

410.603.84 - Advanced Cell Biology I

$4322

Online 5/30 - 8/22

This course covers cell organization and subcellular structure Students examine the evolution of the cell, chromosome, and plasma membrane structures and behaviors; mechanics of cell division; sites of macromolecular synthesis and processing; transport across cell membranes; cell dynamics; organelle biogenesis; and cell specialization. Students are also introduced to the experimental techniques used in cell biology to study cell growth, manipulation, and evaluation.

Technology Fee: $175.00

410.604.81 - Advanced Cell Biology II

$4322

Dr. Jonathon Bennett

Online 5/30 - 8/22

This course is a continuation of 410.603 Advanced Cell Biology and further explores cell organization and subcellular structure Students examine cell-to-cell signaling that involves hormone and receptors, signal transduction pathways, second messenger molecules, cell adhesion, extracellular matrix, cell cycle, programmed cell death, methylation of DNA and modification of chromatic structure, and mechanisms of the cell. The involvement of abnormalities in signal transduction pathway to oncogenes is and other disease states will be stressed. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I.

Technology Fee: $175.00

410.604.82 - Advanced Cell Biology II

$4322

Lisa Selbie

Online 5/30 - 8/22

This course is a continuation of 410.603 Advanced Cell Biology and further explores cell organization and subcellular structure Students examine cell-to-cell signaling that involves hormone and receptors, signal transduction pathways, second messenger molecules, cell adhesion, extracellular matrix, cell cycle, programmed cell death, methylation of DNA and modification of chromatic structure, and mechanisms of the cell. The involvement of abnormalities in signal transduction pathway to oncogenes is and other disease states will be stressed. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I.

Technology Fee: $175.00

410.604.83 - Advanced Cell Biology II

$4322

Lisa Selbie

Online 5/30 - 8/22

This course is a continuation of 410.603 Advanced Cell Biology and further explores cell organization and subcellular structure Students examine cell-to-cell signaling that involves hormone and receptors, signal transduction pathways, second messenger molecules, cell adhesion, extracellular matrix, cell cycle, programmed cell death, methylation of DNA and modification of chromatic structure, and mechanisms of the cell. The involvement of abnormalities in signal transduction pathway to oncogenes is and other disease states will be stressed. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I.

Technology Fee: $175.00

410.610.81 - Epigenetics, Gene Organization & Expression

$4322

Jonathan Lochamy

Online 5/30 - 8/22

Students use genetic analysis and molecular biology techniques to investigate chromosome organization, chromatin structure, functional genomics, and mechanisms of differential gene expression. Other topics include DNA methylation, silencers, enhancers, genomic imprinting, and microarray analysis. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology.

Technology Fee: $175.00

410.612.81 - Human Molecular Genetics

$4322

Erin Morrey

Online 5/30 - 8/22

In this course, students learn to use the tools of modern genomics to elucidate phenotypic variation within populations. The course uses human disease (from simple Mendelian disorders to common, complex disorders) to exemplify the types of studies and tools that can be used to characterize cellular pathophysiology as well as to provide genetic diagnostics and therapies. Students become facile with linkage analysis, cancer genetics, microarray analysis (oligo and DNA arrays), gene therapy, SNP studies, imprinting, disequilibrium mapping, and ethical dilemmas associated with the Human Genome Project. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology.

Technology Fee: $175.00

410.613.81 - Principles of Immunology

$4322

Patrick Cummings

Online 5/30 - 8/22

This course covers molecular and cellular immunology. Topics include innate immunity, adaptive immunity, the development and function of B cell and T cell antigen receptors, the major histocompatibility complexes, innate effector mechanisms, humoral and cellular immune responses, and regulation of immune responses. Special topics include immunomodulation, immunodeficiency diseases, autoimmunity, evasion and subversion of the immune system by pathogens, immunotherapies, and vaccines. Students are also introduced to the applied aspects of immunology, which include protein and cellular based immunoassays. Prerequisites: 410.601 Biochemistry; 410.602 Molecular Biology, 410.603 Advanced Cell Biology I.

Technology Fee: $175.00

410.616.81 - Virology

$4322

Bruce Brown

Online 5/30 - 8/22

This course covers the advanced study of viruses with regard to the basic, biochemical, molecular, epidemiological, clinical, and biotechnological aspects of animal viruses primarily, and bacteriophage, plant viruses, viroid’s, prions, and unconventional agents secondarily. Specific areas of virology, including viral structure and assembly, viral replication, viral recombination and evolution, virus-host interactions, viral transformation, gene therapy, antiviral drugs, and vaccines, are presented. The major animal virus families are discussed individually with respect to classification, genomic structure, viroid structure, virus cycle, pathogenesis, clinical features, epidemiology, immunity, and control. The viral vectors and their application in biotechnology are discussed. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I.

Technology Fee: $175.00

410.621.81 - Agricultural Biotechnology

$4322

Sherry Ogg

Online 5/30 - 8/22

In this course, students are introduced to the application of recombinant DNA technology to agriculture. Studied are methods for the introduction of foreign DNA into plant and animal cells and generation of stably transformed plants and animals. Students consider specific examples of the use of transgenic plants and animals in biotechnology, which can provide protection against insects, diseases, and tolerance to specific herbicides. They also investigate how recombinant growth hormones can result in leaner meat, greater milk yield, and better feed utilization, and how transgenic plants and animals can serve as bioreactors for the production of medicinals or protein pharmaceuticals. Because recombinant agricultural products are released into the environment or consumed as foods, students also need to become familiar with environmental safety issues. Prerequisites: 410.601 Biochemistry 410.602 Molecular Biology, 410.603 Advanced Cell Biology I.

Technology Fee: $175.00

410.622.81 - Molecular Basis of Pharmacology

$4322

Lisa Selbie

Online 5/30 - 8/22

This course begins by reviewing receptor binding and enzyme kinetics. Various cellular receptors and their physiology are discussed, as well as the pharmacological agents used to define and affect the receptor’s function. Students study the pharmacology of cell surface receptors and intracellular receptors. Also considered are the drugs that affect enzymes. Prerequisites: All four core courses.

Technology Fee: $175.00

410.627.81 - Translational Biotechnology:From Intellectual Property to Licensing

$4322

Timothy Alcorn

Online 5/30 - 8/22

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. Students learn to appreciate the importance of quality control and assurance, good manufacturing practices, preclinical and clinical testing, and the lengthy regulatory processes that 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 Bioscience for Regulatory Affairs, OR 410.601 Biochemistry and 410.603 Advanced Cell Biology I or admission to the MS in Regulatory Science OR Master of Biotechnology Enterprise and Entrepreneurship programs.

Technology Fee: $175.00

410.627.82 - Translational Biotechnology:From Intellectual Property to Licensing

$4322

Timothy Alcorn

Online 5/30 - 8/22

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. Students learn to appreciate the importance of quality control and assurance, good manufacturing practices, preclinical and clinical testing, and the lengthy regulatory processes that 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 Bioscience for Regulatory Affairs, OR 410.601 Biochemistry and 410.603 Advanced Cell Biology I or admission to the MS in Regulatory Science OR Master of Biotechnology Enterprise and Entrepreneurship programs.

Technology Fee: $175.00

410.630.81 - Gene Therapy

$4322

Erin Morrey

Online 5/30 - 8/22

Due to recent advances, powerful diagnostics tools can now detect nucleotide changes that are responsible for genetic diseases as well as defects that can influence metabolism of drugs. In this course, using case studies, students will learn general genetic principles, genomic and molecular basis of disease single gene disorders, and the genetic basis for multifactorial diseases including cancer, cardiovascular disease, metabolic disease and neurological disease. The human microbiome and its role in disease will be discussed.  Molecular methods will be emphasized and bioinformatics tools and databases for genomic analysis will be introduced.   Students will discuss the ethical considerations of genetics and genomics.  Pre-requisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Cell Biology I or degree candidate in MS in Individualized Genomics and Health. 

Technology Fee: $175.00

410.633.81 - Introduction to Bioinformatics

$4322

Catherine Campbell

Online 5/30 - 8/22

This course explores the theory and practice of biological database searching and analysis. In particular, students are introduced to integrated systems where a variety of data sources are connected through internet access. Information retrieval and interpretation are discussed, and many practical examples in a computer laboratory setting enable students to improve their data mining skills. Methods included in the course are searching the biomedical literature, sequence homology searching and multiple alignment, phylogeny, gene prediction, protein sequence motif analysis and secondary structure prediction, and several genome browsing methods. Introductory analysis using the R programming language is introduced. Computer access is required. Prerequisites: 410.601 Biochemistry. Corequisite: 410.602 Molecular Biology.

Technology Fee: $175.00

410.633.82 - Introduction to Bioinformatics

$4322

Jarrett Morrow

Online 5/30 - 8/22

This course explores the theory and practice of biological database searching and analysis. In particular, students are introduced to integrated systems where a variety of data sources are connected through internet access. Information retrieval and interpretation are discussed, and many practical examples in a computer laboratory setting enable students to improve their data mining skills. Methods included in the course are searching the biomedical literature, sequence homology searching and multiple alignment, phylogeny, gene prediction, protein sequence motif analysis and secondary structure prediction, and several genome browsing methods. Introductory analysis using the R programming language is introduced. Computer access is required. Prerequisites: 410.601 Biochemistry. Corequisite: 410.602 Molecular Biology.

Technology Fee: $175.00

410.633.83 - Introduction to Bioinformatics

$4322

Md Mizanur Rahman

Online 5/30 - 8/22

This course explores the theory and practice of biological database searching and analysis. In particular, students are introduced to integrated systems where a variety of data sources are connected through internet access. Information retrieval and interpretation are discussed, and many practical examples in a computer laboratory setting enable students to improve their data mining skills. Methods included in the course are searching the biomedical literature, sequence homology searching and multiple alignment, phylogeny, gene prediction, protein sequence motif analysis and secondary structure prediction, and several genome browsing methods. Introductory analysis using the R programming language is introduced. Computer access is required. Prerequisites: 410.601 Biochemistry. Corequisite: 410.602 Molecular Biology.

Technology Fee: $175.00

410.634.81 - Practical Computer Concepts for Bioinformatics

$4322

Jarrett Morrow

Online 5/30 - 8/22

This course introduces students with a background in the life sciences to the basic computing concepts of the UNIX operating system, relational databases, structured programming, object-oriented programming, and the Internet. Included is an introduction to SQL and the Pythonl scripting language. The course emphasizes relevance to molecular biology and bioinformatics. It is intended for students with no computer programming background but with a solid knowledge of molecular biology. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology.

Technology Fee: $175.00

410.634.82 - Practical Computer Concepts for Bioinformatics

$4322

Joshua Orvis

Online 5/30 - 8/22

This course introduces students with a background in the life sciences to the basic computing concepts of the UNIX operating system, relational databases, structured programming, object-oriented programming, and the Internet. Included is an introduction to SQL and the Pythonl scripting language. The course emphasizes relevance to molecular biology and bioinformatics. It is intended for students with no computer programming background but with a solid knowledge of molecular biology. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology.

Technology Fee: $175.00

410.638.81 - Cancer Biology

$4322

Meredith Safford

Online 5/30 - 8/22

This course provides students with knowledge of the fundamental principles of the molecular and cellular biology of cancer cells. The course explores the role of growth factors and signal transduction mechanisms, oncogenes, tumor suppressor genes, tumor viruses, and angiogenesis in tumorigenesis and metastasis. Special topics include cancer prevention and the array of cancer therapies, which include surgery, chemotherapy, radiation therapy, hormonal therapy, stem cell transplant, and immunotherapies. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cellular Biology I , 410.604 Advanced Cell Biology II.

Technology Fee: $175.00

410.639.81 - Protein Bioinformatics

$4322

Online 5/30 - 8/22

Because the gap between the number of protein sequences the number of protein crystal structures continues to expand protein structural predictions are increasingly important. This course provides a working knowledge of various computer- based tools available for predicting the structure and function of proteins. Topics include protein database searching, protein physicochemical properties, secondary structure prediction, a statistical verification. Also covered are graphic visualization the different types of three-dimensional folds and predicting 3-D structures by homology. Computer laboratories complement material presented in lectures. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.633 Introduction to Bioinformatics.

Technology Fee: $175.00

410.640.81 - Molecular Phylogenetic Techniques

$4322

Elizabeth Humphries

Online 5/30 - 8/22

This course will provide a practical, hands-on introduction to the study of phylogenetics and comparative genomics. Theoretical background on molecular evolution will be provided only as needed to inform the comparative analysis of genomic data. The emphasis of the course will be placed squarely on the understanding and use of a variety of computational tools designed to extract meaningful biological information from molecular sequences. Lectures will provide information on the conceptual essence of the algorithms that underlie various sequence analysis tools and the rationale behind their use. Only programs that are freely available, as either downloadable executables or as Web servers, will be used in this course. Students will be encouraged to use the programs and approaches introduced in the course to address questions relevant to their own work. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.633 Introduction to Bioinformatics.

Technology Fee: $175.00

410.645.81 - Biostatistics

$4322

William McCarthy

Online 5/30 - 8/22

This course introduces statistical concepts and analytical methods as applied to data encountered in biotechnology and biomedical sciences. It emphasizes the basic concepts of experimental design, quantitative analysis of data, and statistical inferences. Topics include probability theory and distributions; population parameters and their sample estimates; descriptive statistics for central tendency and dispersion; hypothesis testing and confidence intervals for means, variances, and proportions; categorical data analysis; linear correlation and regression model; logistic regression; analysis of variance; and nonparametric methods. The course provides students a foundation to evaluate information critically to support research objectives and product claims and a better understanding of statistical design of experimental trials for biological products/devices. Prerequisites: Basic mathematics (algebra).

Technology Fee: $175.00

410.648.81 - Clinical Trial Design and Conduct

$4322

Christopher Breder

Online 5/30 - 8/22

Through a case study approach, this course will cover the basic design issues of clinical trials, specifically targeting the protocol, case report forms, analysis plan, and informed consent. The design of a specific trial will be studied to illustrate the major issues in the design of a study, such as endpoint definition, control group selection, and eligibility criteria. The course will also cover the analysis plan for a study, including approaches that are central to clinical trials, such as stratified analysis, adjustment factors, and “intention-to-treat” analysis. The planned analytical techniques will include the analysis of correlated data (i.e., clustered data, longitudinal data), survival analysis using the proportional hazards (Cox) Regression model, and linear models. A semester-long project will include the creation of a protocol, case report forms, and informed consent. Prerequisites: 410.645 Biostatistics or equivalent (required), 410.651 Clinical Development of Drugs and Biologics (recommended).

Technology Fee: $175.00

410.649.81 - Introduction to Regulatory Affairs

$4322

Susan Zecchini

Online 5/30 - 8/22

Regulatory affairs comprise the rules and regulations govern product development and post-approval marketing. In the U.S. the FDA establishes and oversees the applicable regulations under several statutes, many regulations, and partnership with legislators, patients, and customers. Biotechnology products may be classified as drugs, biologics, or medical devices. Each type is regulated by a different center within the FDA. This course provides an overview of RA and its effect on product development. Topics include RA history, regulatory agencies, how to access regulatory information, drug submissions, biologics submissions, medical device submissions, GLP, GCP, GMP, and FDA inspections.

Technology Fee: $175.00

410.649.82 - Introduction to Regulatory Affairs

$4322

Alison St John

Online 5/30 - 8/22

Regulatory affairs comprise the rules and regulations govern product development and post-approval marketing. In the U.S. the FDA establishes and oversees the applicable regulations under several statutes, many regulations, and partnership with legislators, patients, and customers. Biotechnology products may be classified as drugs, biologics, or medical devices. Each type is regulated by a different center within the FDA. This course provides an overview of RA and its effect on product development. Topics include RA history, regulatory agencies, how to access regulatory information, drug submissions, biologics submissions, medical device submissions, GLP, GCP, GMP, and FDA inspections.

Technology Fee: $175.00

410.651.81 - Clinical Development of Drugs and Biologics

$4322

Jonathan Helfgott
Michael Marcarelli

Online 5/30 - 8/22

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 International Council for Harmonisation regulations and guidelines. Because the course emphasizes the importance of planning before the execution of any of the necessary steps, lectures use a “backward” 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: 410.303 Foundations of Bioscience OR 410.601 Biochemistry and 410.603 Advanced Cell Biology OR admission to the MS in Regulatory Science Program OR Master of Biotechnology Enterprise and Entrepreneurship programs.

Technology Fee: $175.00

410.651.82 - Clinical Development of Drugs and Biologics

$4322

Bharat Khurana

Online 5/30 - 8/22

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 International Council for Harmonisation regulations and guidelines. Because the course emphasizes the importance of planning before the execution of any of the necessary steps, lectures use a “backward” 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: 410.303 Foundations of Bioscience OR 410.601 Biochemistry and 410.603 Advanced Cell Biology OR admission to the MS in Regulatory Science Program OR Master of Biotechnology Enterprise and Entrepreneurship programs.

Technology Fee: $175.00

410.655.81 - Radiation Biology

$4322

Thomas Koval

Online 5/30 - 8/22

This course will review types of ionizing radiation and their differences, physical and chemical interactions of radiation w key biological molecules, and effects on living matter beginning with molecular and cellular interactions and proceeding to tissue, organ, and organism levels, emphasizing the human system. Radiation’s beneficial effects in cancer therapy and medicine as well as detrimental and carcinogenic effects will be discussed. Specific units will consider food irradiation, nuclear power plant accidents, radiation terrorism, everyday sources exposure to the U.S. population, and other practical situations involving radiation. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I.

Technology Fee: $175.00

410.673.81 - Biological Processes in Regulatory Affairs

$4322

Markus Yap

Online 5/30 - 8/22

This course provides an overview of the biological processes laboratory techniques utilized for the discovery, development and evaluation of therapeutic drugs. Students investigate drug development processes, such as gene cloning, culture scale-u downstream processing, and product purification. Emphasis is placed on the theory and application of laboratory methods u in drug development, such as recombinant DNA techniques, antibody technology, protein purification, immunoassays, high throughput drug screening, chromatography, electrophoresis cell receptor characterization, pharmacokinetics, drug toxicity testing and evaluation of therapeutic drugs, diagnostics, and vaccines. Prerequisites: 410.303 Bioscience for Regulatory Affairs, OR 410.601 Biochemistry and 410.603 Advanced Cell Biology OR admissions to the MS in Regulatory Science OR Master of Biotechnology Enterprise and Entrepreneurship programs.

Technology Fee: $175.00

410.673.82 - Biological Processes in Regulatory Affairs

$4322

Michael Manning

Online 5/30 - 8/22

This course provides an overview of the biological processes laboratory techniques utilized for the discovery, development and evaluation of therapeutic drugs. Students investigate drug development processes, such as gene cloning, culture scale-u downstream processing, and product purification. Emphasis is placed on the theory and application of laboratory methods u in drug development, such as recombinant DNA techniques, antibody technology, protein purification, immunoassays, high throughput drug screening, chromatography, electrophoresis cell receptor characterization, pharmacokinetics, drug toxicity testing and evaluation of therapeutic drugs, diagnostics, and vaccines. Prerequisites: 410.303 Bioscience for Regulatory Affairs, OR 410.601 Biochemistry and 410.603 Advanced Cell Biology OR admissions to the MS in Regulatory Science OR Master of Biotechnology Enterprise and Entrepreneurship programs.

Technology Fee: $175.00

410.674.81 - Food Microbiology

$4322

Om Singh

Online 5/30 - 8/22

Food microbiology encompasses the study of microorganisms that have both beneficial and deleterious effects on the quality and safety of raw and processed meat, poultry, and egg products. Food microbiology focuses on the general biology of the microorganisms that are found in foods, including their growth characteristics, identification, and pathogenesis. Specifically, areas of interest that concern food microbiology are food poisoning, food spoilage, food preservation, and food legislation. Pathogens in product, or harmful microorganisms, result in major public health problems in the United States and worldwide, and are the leading causes of illnesses and death.

Technology Fee: $175.00

410.675.81 - International Regulatory Affairs

$4322

Suzanne Fitzpatrick

Online 5/30 - 8/22

Pharmaceutical/biotechnology product approval and marketing requires a good understanding of international regulatory affairs in order to successfully compete in today’s global marketplace. It is important for tomorrow’s leaders to understand and follow the regulatory differences to ensure optimum product development strategies, regulatory approvals, and designs for exports conforming to the foreign regulatory bodies. There are various product development strategies that industry is using to shorten the product development time by conducting preclinical programs outside the U.S., but the strategy requires careful planning and interaction with the U.S. and foreign regulatory agencies. With the increase in globalization of economy and exports, international regulations will have a bigger impact on the biotechnology business in the future. The course provides a review and analysis of the pharmaceutical/biotechnology product approval processes within the world’s major markets. The key strategies required in preclinical product development to marketing approval of the products in Europe, Japan, and the U.S. will be compared and discussed. Students will explore the European Union regulations and their overall importance on international markets. The course will cover the salient features of common technical and regulatory documents required for submission and approval to the leading regulatory bodies in the world, general guidance documents, international harmonization, and the General Agreement on Tariffs and Trade.

Technology Fee: $175.00

410.676.81 - Food And Drug Law

$4322

Loretta Chi

Online 5/30 - 8/22

The Food, Drug, and Cosmetic Act governs the regulatory approval process for bringing a drug, biologic, medical device, food, or cosmetic to market. The class will discuss administrative procedures followed by the FDA. The course includes an overview of the drug, biologic, and medical device approval processes, and the regulation of food and dietary supplements. Students then will be exposed to the enforcement activities of the FDA, including searches, seizure actions, injunctions, criminal prosecutions, and civil penalties authorized under the FD&C Act, as well as other statutes, like the Public Health Service Act which regulates the development and approval of biologics.

Technology Fee: $175.00

410.676.82 - Food And Drug Law

$4322

Emil Wang

Online 5/30 - 8/22

The Food, Drug, and Cosmetic Act governs the regulatory approval process for bringing a drug, biologic, medical device, food, or cosmetic to market. The class will discuss administrative procedures followed by the FDA. The course includes an overview of the drug, biologic, and medical device approval processes, and the regulation of food and dietary supplements. Students then will be exposed to the enforcement activities of the FDA, including searches, seizure actions, injunctions, criminal prosecutions, and civil penalties authorized under the FD&C Act, as well as other statutes, like the Public Health Service Act which regulates the development and approval of biologics.

Technology Fee: $175.00

410.679.81 - Practicum in Regulatory Science

$4322

Thomas Colonna

Online 5/30 - 8/22

This integrative, case-based course will focus on applying knowledge gained from previous courses in the Master of Science in Regulatory Science program to actual cases from the FDA. For each case, students will assume the role of regulatory specialist, an FDA reviewer or senior-level policy-maker, or other involved stakeholders, such as a consumer group or an advocacy group. Students will be expected to research, evaluate, and present scientifically and legally justifiable positions on case studies from the perspective of their assigned roles. Students will present their perspectives to the class and be asked to debate the issues with the other students from the perspective of their assigned roles. The major responsibility of the students in this course will be to make scientifically and legally defensible recommendations and to justify them through oral and written communication. Please note this course is only open to students in the Master of Science in Regulatory Science and should only be taken after all required courses are completed.

Technology Fee: $175.00

410.683.81 - Introduction to cGMP Compliance

$4322

Nancy Karaszkiewicz

Online 5/30 - 8/22

Current Good Manufacturing Practice regulations are the minimum standards for the design, production, and distribute of drugs, biologics, and medical devices in the U.S. and internationally. In the U.S., they are codified at the federal level, in the FD&C Act and the Code of Federal Regulations, and actively enforced by FDA. These regulations, however, only begin to describe the practices used in the pharmaceutic and biotech industries. Additional sources of insight and guidance include the FDA’s guidance documents and training manuals, industry trade publications, international compendia and standards-setting organizations. Students will learn the scope and history of the regulations, industry-standard implementation strategies and “best-practices” approaches, and the FDA’s current expectations. Students will also learn to apply practical solutions to the regulatory issues faced in the pharmaceutical and biotech industries today.

Technology Fee: $175.00

410.683.82 - Introduction to cGMP Compliance

$4322

Nancy Karaszkiewicz

Online 5/30 - 8/22

Current Good Manufacturing Practice regulations are the minimum standards for the design, production, and distribute of drugs, biologics, and medical devices in the U.S. and internationally. In the U.S., they are codified at the federal level, in the FD&C Act and the Code of Federal Regulations, and actively enforced by FDA. These regulations, however, only begin to describe the practices used in the pharmaceutic and biotech industries. Additional sources of insight and guidance include the FDA’s guidance documents and training manuals, industry trade publications, international compendia and standards-setting organizations. Students will learn the scope and history of the regulations, industry-standard implementation strategies and “best-practices” approaches, and the FDA’s current expectations. Students will also learn to apply practical solutions to the regulatory issues faced in the pharmaceutical and biotech industries today.

Technology Fee: $175.00

410.684.81 - Technology Transfer & Commercialization

$4322

Reid Adler

Online 5/30 - 8/22

This course is an introduction to the multidisciplinary aspect involved in the process of translating innovations in technology into commercial use, particularly research discoveries emanating from universities and other nonprofit organization.

Technology Fee: $175.00

410.693.81 - Science, Medicine & Policy in Biodefense

$4322

Sara Ruiz

Online 5/30 - 8/22

This course provides a comprehensive introduction to the Concentration in Biodefense. Biological warfare is introduced in its historical context, followed by the properties of the most important biological threat agents, their medical consequences and treatment, diagnostics, and forensics. Relevant international and domestic policy issues are explored, along with defense strategies and the nature of existing dangers to national security. Students should leave the class with a deep understanding of biological warfare and terror agents, the consequences of their potential use, and the available means of protection. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I, undergraduate microbiology or 410.615 Microbiology.

Technology Fee: $175.00

410.694.81 - FDA Premarket Applications

For the virtual learning environment, see CourseWork Course Management System.

Coursework is work performed by students or trainees for the purpose of learning. Coursework may be specified and assigned by teachers, or by learning guides in self-taught courses. Coursework can encompass a wide range of activities, including practice, experimentation, research, and writing (e.g., dissertations, book reports, and essays). In the case of students at universities, high schools and middle schools, coursework is often graded and the scores are combined with those of separately assessed exams to determine overall course scores. In contrast to exams, students may be allotted several days or weeks to complete coursework, and are often allowed to use text books, notes, and the Internet for research.

In universities, students are usually required to perform coursework to broaden knowledge, enhance research skills, and demonstrate that they can discuss, reason and construct practical outcomes from learned theoretical knowledge. Sometimes coursework is performed by a group so that students can learn both how to work in groups and from each other.

Plagiarism and other problems[edit]

Plagiarism and copying can be problematic in graded coursework. Easily accessible websites have given students opportunities to copy ideas and even complete essays, and remain undetected despite measures to detect this. While coursework may give learners the chance to improve their grades, it also provides an opportunity to "cheat the system". Also, there is often controversy regarding the type and amount of help students can receive while performing coursework. In most learning institutions, plagiarism or unreasonable coursework help may lead to coursework disqualification, student expulsion, or both.

In the UK

Coursework was removed from UK GCSE courses and replaced by "Controlled Assessment", much of which must be completed under exam conditions, without teacher assistance and with access to resources tightly controlled in order to reduce the possibility of cheating.[1] However, this too will shortly be largely removed and replaced by mainly exam-based assessment as part of a general GCSE reform.[2]

See also[edit]

References[edit]

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