Columbia University in the City of New York · Courses
BIOT GU
5 courses with the subject BIOT GU, each shown exactly as we captured it from the college's catalog, with every element we hold. Where the wording looks broken, that is our reading of the catalog, not the college's text.
BIOT GU4160BIOTECHNOLOGY LAW3.00
Prerequisites: at least 4 college-level biology or biotechnology courses. This course will introduce students to the interrelated fields of patent law, regulatory law, and contract law that are vital to the biotech and biopharmaceutical sectors. The course will present core concepts in a way that permits students to use them throughout their corporate, academic, and government careers. SCE and TC students may register for this course, but they must first obtain the written permission of the instructor, by filling out a paper Registration Adjustment Form (Add/Drop form). The form can be downloaded at the URL below, but must be signed by the instructor and returned to the office of the registrar. http://registrar.columbia.edu/sites/default/files/content/reg-adjustment.pdf
Prerequisites: BIOT GU4160 BIOTECHNOLOGY LAW (BIOT W4160) This course – the first of its kind at Columbia – introduces students to a vital subfield of ethics focusing on patent and regulatory law in the biotech and pharmaceutical sectors. The course combines lectures, structured debate, and research to best present this fascinating and nuanced subject. Properly exploring this branch of bioethics requires an in-depth understanding of biotech and pharmaceutical patent and regulatory law. Students can gain this understanding by first completing Biotechnology Law (BIOT GU4160), formerly the prerequisite for this course. Now, they can also gain it by reading the appropriate chapters of Biotechnology Law: A Primer for Scientists (the textbook for BIOT GU4160 published earlier this year) prior to each class. A number of students in the biotechnology fields (such as those in biotechnology, biomedical engineering, and bioethics programs) have shown a keen interest over the years in taking this course, yet were unable to do so because they hadn’t taken BIOT GU4160. Given the recent publication of Biotechnology Law and the desirability of making BIOT GU4161 accessible to more students having the appropriate science background, BIOT GU4160 has been removed as a prerequisite
Prerequisites: the instructors permission. The course examines the entrepreneurial process in biotechnology from idea generation through economic viability. Biotechnology companies are unique in that they need a years-to-decades long period of incubation prior to becoming self-sustaining. Students will be introduced to the steps needed to start and nurture a company, and gain an ability to assess the health of potential collaborators, partners or employers. Topics include an overview of the global biotechnology industry, idea generation, business plan formulation, intellectual property protection, funding, personnel management including board composition, regulatory body interaction, and company exits. Course website: http://biot4180.weebly.com/
The program aims to provide current life sciences students with an understanding of what drives the regulatory strategies that surround the development decision making process, and how the regulatory professional may best contribute to the goals of product development and approval. To effect this, we will examine operational, strategic, and commercial aspects of the regulatory approval process for new drug, biologic, and biotechnology products both in the United States and worldwide. The topics are designed to provide a chronological review of the requirements needed to obtain marketing approval. Regulatory strategic, operational, and marketing considerations will be addressed throughout the course. We will examine and analyze the regulatory process as a product candidates are advanced from Research and Development, through pre-clinical and clinical testing, to marketing approval, product launch and the post-marketing phase. The goal of this course is to introduce and familiarize students with the terminology, timelines, and actual steps followed by Regulatory Affairs professionals employed in the pharmaceutical or biotechnology industry. Worked examples will be explored to illustrate complex topics and illustrate interpretation of regulations
Prerequisites: BIOT W4200 (OK without prerequisite). This course will provide a practical definition of the current role of the Regulatory Professional in pharmaceutical development, approval and post-approval actions. This will be illustrated by exploration, and interactive discussion of regulatory history, its evolution, current standards, and associated processes. The course will seek to clarify the role of Regulatory in development and lifecycle opportunities, demonstrating the value Regulatory adds by participation on research, development and commercial teams. The course will utilize weekly case studies and guest lecturers to provide color to current topical events related to the areas
