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BIOT W4200x - Biotechnology: Biopharmaceutical Dev & Reg

Course Description:

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.

Instructors: Ron Guido/Alan McEmber

Number of Credits: 3
Semester: fall  2009

Course Sections

Section Number: 001
Location: 1000 Fairchild
Days of the Week: Thursday
Start Time: 3:40 pm
End Time: 5:40 pm
Course Website: http://www.columbia.edu/cu/biology/courses/w4200/
Instructor: Ron Guido

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