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Regulation of Drugs & Biologics: Strategic Biopharmaceutical Product Development | REGL.X411

Complex regulations govern the development, manufacture, and commercialization of biomedical products. This course helps participants understand the regulatory requirements, both U.S. and international, for patented and generic pharmaceuticals, over-the-counter drugs, and biological products. This course also provides the basics of regulatory strategy in biopharmaceutical development examining the various regulatory pathways. Through lectures, case studies, and hands-on exercises, students gain knowledge and insight into the regulatory agencies and their roles and responsibilities, regulatory applications and pathways, post-marketing requirements, the impact of regulatory differences between U.S. and other countries, and how regulatory approval processes affect corporate strategy. The requirements and logistics of regulatory submissions will also be explored.

Learning Outcomes:
At the end of the course, students should be able to

  • Discuss FDA’s jurisdiction and the reason for food, drug, and cosmetic laws
  • Define the various regulatory pathways available for biopharmaceutical products
  • Understand individual roles/responsibilities and how the biopharmaceutical industry works in general

STUDENTS: if you have taken and passed REGL.x403, you do not have to take REGL.x411 under the updated / new requirements for Track 1. REGL.x411 incorporates content that was in REGL.x403 and REGL.x406.

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Call (408) 861-3860
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This course is related to the following programs:


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Call (408) 861-3860

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