<p>This course provides a comprehensive introduction to trial phases and design for drug and medical device lifecycle development. Students will build foundational knowledge in medical terminology, Good Clinical Practice (GCP), the responsibilities of…
Continuing · professional · extension education
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Master the role of regulatory affairs in the successful licensure of products globally, including responsibilities and reporting relationships. Using case studies, learn to understand the similarities and differences in worldwide requirements for product…
Study the common molecular processes and chemical reactions that underlie diverse life forms. Begin by examining the relationship between the 3-D structure of proteins and their biological activity. Next, look at the mechanism of enzyme action, how enzymes…
<span>Study the physiology of the human endocrine system and learn about diseases that manifest with its dysfunction. You learn in depth about the structure and function of the major endocrine glands; molecular classification of hormones; how molecular…
<p>Learn fundamental concepts in biology, including prokaryotes; protists; fungi and plant development, form and function; population genetics; ecology; conservation; the origin of life; evolution; and classification. Designed for biology majors and…
<p>Get an introduction to the fundamental concepts of inorganic chemistry, including matter, atoms, molecules, solutions, thermochemistry, chemical bonding and intermolecular forces. Develop laboratory skills such as instrumentation, data analysis and…
Gain an introduction to fundamental concepts in biology, including cell structure and function; prokaryotes; eukaryotes; metabolism; molecular and organismal genetics; classification; and animal development, form and function. Designed for biology majors and…
<p>Get an introduction to the fundamental concepts of inorganic chemistry, including matter, atoms, molecules, solutions, thermochemistry, chemical bonding and intermolecular forces. This course is designed for biology, premedical and prehealth students. It…
<p>Study the fundamental concepts of inorganic chemistry, including properties of solutions, kinetics, equilibria, electrochemistry, nuclear chemistry, metals, nonmetals and other topics of interest. This course is aimed at biology, premedical and prehealth…
<p>This course provides a comprehensive introduction to clinical trial planning including data management, clinical trial database design, case report forms (CRFs), as well as protocol development and informed consent requirements. The curriculum examines…
Understand the role of regulatory affairs in the course of clinical trials. In addition to learning roles and responsibilities, study how they interface between the professional and other departments and the regulatory bodies. Using case studies, master the…
Explore immunohematology, or blood banking, a specialized field of laboratory medicine that involves the study of antigens and antibodies and how they relate to the development and clinical manifestation of blood disorders. During the course, you focus on…
<p>This course provides a comprehensive overview of the documentation, regulatory requirements, and operational procedures essential for clinical trial implementation. Students will learn how to manage master and investigator files, initiate investigational…
<p>This course offers a comprehensive overview to full data lifecycle from vendor selection and data management setup through data entry, review, cleanup, statistical analysis, and clinical study report (CSR) development vendor selection. Students will learn…
Get an introduction to pharmaceutical product development and the concomitant Chemistry, Manufacturing and Controls (CMC) requirements by regulatory agencies. As drug development moves from concept to commercialization, the breadth and depth of CMC…
<p>Learn about recent scientific advances and emerging technologies in molecular and cell biology, neurobiology, genomics, immunology and infectious disease. Read current scientific literature, and learn how to analyze experimental data and critically…
How does a single cell, the fertilized egg, give rise to a complex organism that contains many different cell types, tissues and organs? How do the organs develop to the right size and in the right place to give rise to a functional animal? Developmental…
<p>Get an introduction to fundamental concepts in biology, including cell structure and function; metabolism; molecular and organismal genetics; classification; and animal development, form and function. Designed for biology majors and premedical and…
<p>Learn fundamental concepts in biology, including prokaryotes; protists; fungi and plant development, form and function; population genetics; ecology; conservation; the origin of life; evolution; and classification. Designed for biology majors and…
<p>Learn the fundamental concepts of inorganic chemistry, including properties of solutions, kinetics, equilibria, thermodynamics, electrochemistry, nuclear chemistry, metals, nonmetals and other topics of interest. Develop laboratory skills such as…
Genome sequencing is the driving force behind precision medicine, where knowledge of genome variation is leading to more precise diagnosis, treatment and prevention of disease. Understanding how to discern between pathogenic (disease-causing) and benign…
Investigate the human genome and various types of sequence variation, as well as their clinical consequences. This course covers methodologies used to uncover associations between genome variation and disease/drug response. Learn to interpret genomic test…
Gain an understanding of the role of quality assurance (QA) in the functional plants that make materials for clinical trials and commercial operations. Understand the role of QA in a functional Good Manufacturing Practices (GMP) plant. Using case studies,…
Gain an understanding of the quality control function and the difference between quality assurance (QA) and quality control (QC) and the role and function of the QC department. Learn to critically understand what industry regulations require and how to apply…
<p>Learn to master the written parts of your application to graduate-level health profession programs (medical, dental, veterinary, advanced nursing, pharmacy, physical therapy, physician assistant, public health, optometry and other health care programs).…
<p>Learn effective strategies and techniques to interview successfully for your desired graduate-level professional school (medical, dental, veterinary, advanced nursing, pharmacy, physical therapy, physician assistant, public health, optometry and other…
<p>Understand the process of applying to graduate-level health profession programs (medical, dental, veterinary, advanced nursing, pharmacy, physical therapy, physician assistant, public health, optometry and other health care programs). After receiving a…
Focus on the correlation between the structure and function of the various body systems, and examine topics such as the nervous, endocrine, cardiovascular and reproductive systems. Become familiar with dissection and basic microscopic examination of tissues.…
Study the fundamental concepts of human physiology—including reproductive, neural, muscular, cardiovascular, respiratory, renal, endocrine and sensory systems—using hands-on experiments and computer simulations. Measure and analyze student EKGs, blood…
<h3><strong>Note: This will be the final offering of this course.</strong> It will be replaced by IND/CTA Preparation, Submission and Agency Interfacing PB HLTH X404.8 in Fall 2019. The new course combines this class with IND/CTA Preparation and Submission PB…
<h3><strong>Note: This will be the final offering of this course.</strong> It will be replaced by IND/CTA Preparation, Submission and Agency Interfacing PB HLTH X404.8 in Fall 2019. The new course combines this class with IND/CTA Enabling Studies and Agency…
<p>Regulatory affairs plays an important role during the first stages of product development in ensuring that all appropriate studies are performed to prepare and submit the investigational new drug application and clinical trial application (IND/CTA).…
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