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Oct 22, 2020
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Information Select the Course Number to get further detail on the course. Select the desired Schedule Type to find available classes for the course.

PHA 730 - Regulatory Affairs
The course provides foundational, knowledge of pharmaceutical, biotechnology and medical device industries and the position and duties of the office of Regulatory Affairs is an integral part of the organizational structure of the company. It liaises at the interphase of drug development, manufacturing, marketing and clinical research and is the key interface between the company and the national or international regulatory authorities. The course includes company organization and commercialization activities, e.g., drug discovery, chemical synthesis, product development, quality assurance, manufacturing, quality control and pharmacovigilance, clinical research, marketing and post-marketing surveillance. [3-0, 3 cr.]
3.000 Credit hours
3.000 Lecture hours

Levels: Graduate
Schedule Types: Lecture, Tutorial

Pharmacy Division
Pharmacy Department

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