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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.
Practical Aspects of Regulatory Compliance
RA 3206 / 4 q.h.
Boston |
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