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Introduction to Drug and Medical Device Regulation
RA 3100 / 4 q.h.
June 25 - August 18
Online
This course provides an overview of drug, Biologics, and device development and the FDA. Through course work and discussion, students will gain the foundations necessary to build a strong understanding of regulatory affairs. Topics include the historic development of U.S. drug laws, law vs. regulation, FDA and industry functions, policy-guided science, and cases shaping history into the present state of regulation.
Biologics Development: A QA/Regulatory Overview
RA 3200 / 4 q.h.
June 25 - August 18
Boston 5:15 PM-8:35 PM
In this course, students will conduct a comprehensive and up-to-date analysis of the post-reform FDA Center for Biologics Evaluation and Research (CBER) and the complete U.S. biological product approval process, from preclinical testing to postmarketing regulatory requirements. The course includes both CBER official and industry expert perspectives on quality assurance issues and related regulatory topics in successfully bringing biologics to market, as well as current Good Manufacturing Practice regulations to assure quality of marketed products.
Food, Drug, and Medical Device Law: Topics and Cases
RA 3203 / 4 q.h.
June 25 - August 18
Boston Tu 5:15 PM-8:35 PM
This course provides a comprehensive analysis of current food, drug and medical device laws. Students will undertake a detailed review of legislation and landmark cases, as well as laws governing development, manufacture and commercial distribution of drugs, biologics, and medical device products, and how they relate to the biotechnology, pharmaceutical, and medical device industries.
Emerging Trends and Issues in the Medical Device Industry
RA 3205 / 4 q.h.
June 25 - August 18
Online
Class discussions will focus on trends expected to have a significant effect on the future of the medical device industry including the aging population; the need for devices that treat chronic illnesses such as renal failure, congestive heart failure, heart abnormalities, arthritis and diabetes; reimbursement issues arising from the huge financial burden placed on Medicare and insurance companies in picking up the increased cost of healthcare; lifestyle changes with an increased demand for devices that improve one's quality of life or appearance; reuse of single-use disposable devices to cut costs; group purchasing practices, outpatient treatment; telemedicine, regulatory/legal requirements; and the movement of devices into new areas, such as coating stents with pharmaceutical/biological agents and using patches to deliver pharmaceutical agents.
Practical Aspects of Regulatory Compliance
RA 3206 / 4 q.h.
Boston
Global Biotechnology Product Registration: E.U., U.S., and Japan
RA 3220 / 4 q.h.
June 25 - August 18
Online
This course provides a comprehensive and up-to-date analysis of the biotechnology product approval process within each of the world's three most critical biopharmaceutical markets. From preclinical product development to post-marketing approval, students will explore aspects of biopharmaceutical regulatory analyses in the three regions of the world that together represent more than 75 percent of the global market for biopharmaceuticals.
European Union Compliance Process and Regulatory Affairs
RA 3221 / 4 q.h.
June 25 - August 18
Online
This course provides a clear-cut picture of the European Union (EU) and how EU Directives are impacting international business. By illustrating how companies need to approach compliance, students will be guided through compliance issues and gain an understanding of the relationship between compliance and CE Marking. The risks and rewards of CE Marking and an overview of liability laws in the EU are also discussed. |
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