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Module PATENTING, EVALUATION AND LICENSING OF BIOLOGICAL PRODUCTS

Module code: BI857
Credits: 2.5
Semester: 2
Department: BIOLOGY
International: No
Overview Overview
 

Following discovery of a new biological product or process in the laboratory, the first step to commercialization is to establish intellectual property rights by submitting a patent application. This involves a thorough search of existing patents in the area and close scrutiny of submitted material, including supporting experimental data, by national and international patent agencies. Once a patent has been issued the next step is to seek an industrial partner or raise the finance to scale up production and begin the process of evaluation prior to licensure. The transition of a biological product (e.g. vaccine or blood product) from laboratory to the market place requires evaluation in humans in clinical trials and approval by regulatory authorities. Biological products are evaluated in a sequence of clinical trials, which provide increasingly stringent tests on safety and efficacy. Successful completion of three phases of clinical trials is normally required prior to licensure, after which further observational studies are undertaken to monitor performance in the field. The World Health Organization (WHO) establishes minimal requirement for biological products, which form the basis for assuring acceptability of products globally. In general they specify the need for appropriate starting materials, including seed pools; strict adherence to established protocols; tests for purity, potency, and safety at specific steps during production; and the keeping of proper records. These requirements provide guidelines for those responsible for production and control procedures and national regulatory Authorities, such as the Food & Drug Administration (FDA) in the US or the Irish Medicines Board usually adopt them. Each product has to be approved by the local regulatory authority prior to marketing in that country.

Please note places on BI857 are limited. Interested students should email the Biology Administrator at biology.department@mu.ie (with your MU student number)before registering. A timetable will be given when your place is confirmed.

Open Teaching & Learning methods
 
Open Assessment
 
Open Pre-Requisites
 
Open Timetable
 
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