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Course Details

Course Number: 90-788

Biotechnology Regulations, Policy, and Compliance

Units: 6

Regulatory compliance affects all aspects of the biotechnology and biomedical industries beginning with research activities and clinical trials through regulatory filings and the approvals required before products can be released for sale. Compliance can be mandated by governmental bodies such as the US FDA or voluntary as with ISO certification. To complicate the landscape, regulatory requirements vary by country, region, and locality.

This course will examine the breadth of compliance issues facing organizations in the biotechnology and biomedical industry as well as both the challenges and opportunities driven by regulatory policies. We will discuss the impact of regulatory compliance on both established and emerging business including the influence of compliance issues on strategy, budget, fund raising, and market.

The course will focus on the regulatory environment in the United States but will also include discussions of issues mandated by international commerce and the future of policy driven by both product safety, product efficacy, and by homeland security issues.

Faculty:
Harold Safferstein