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BIOTECHNOLOGY REGULATION AND ETHICS

BIOMDSCI 801
과목 설명

Explore political, legal, and ethical issues and paradigms that drive product development within the biotechnology industry with special emphasis given to how new drugs, devices, and biologics are regulated by local, national, and global agencies. Describe the regulations and ethics of human subjects' research. Develop skills to support how regulation and politics interact with business and finance to influence the formation and growth of biotechnology companies. Discuss how ethics and regulatory policy influence how biotechnology products come to market.

선수과목

Declared in Biotechnology MS

충족 요건

This course does not satisfy any prerequisites.

학점

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개설 시기

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평점
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변화 계산 불가

수료율
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변화 계산 불가

A 비율
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변화 계산 불가

학급 규모
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과거 데이터 대비 변화 없음

데이터 없음

강사 (2026 Summr)

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유사 과목

SURVEY OF QUALITY ASSURANCE AND REGULATORY AFFAIRS IN BIOTECHNOLOGY

BIOMDSCI 720

Success in the biotechnology industry is based on learning the language and understanding the development process utilized in bringing products to market. Focus on techniques used in the biotechnology industry to comply with the quality and regulatory requirements set forth by professional and governmental agencies in the effort to develop, manufacture, and commercialize products safely for the public.

ETHICS, SAFETY, AND REGULATORY ENVIRONMENTS IN BIOTECHNOLOGY

ABT 705

Ethical and safety concerns in development, production, funding, and application of biotechnology. Analysis of socioeconomic impacts. Understanding the importance of data integrity. Overview of risk assessment and management in a regulatory environment designed to ensure safety of workers, study subjects, and patients, and protect intellectual property, data, and the environment.

ADVANCED BIOTECHNOLOGY: GLOBAL PERSPECTIVES

BIOMDSCI 831

Investigate state-of-the-art topics of global importance to biotechnology. Integrated skills and knowledge to achieve synergistic levels of understanding the importance of biotechnology today. Formulate the scientific, ethical, and regulatory standards used in the development of novel technologies around the globe. Increase awareness for intellectual collaboration and entrepreneurship opportunities.

TOPICS IN QUALITY ASSURANCE AND REGULATORY AFFAIRS IN BIOTECHNOLOGY

BIOMDSCI 721

Quality Assurance and Regulatory Affairs departments influence and facilitate successful product development within the biotechnology industry. Use a case study approach to explore and apply how quality assurance and regulatory compliance systems are used to bring medical devices to market. Practice how cross functional teams work together to meet regulatory standards of safety.

REGULATORY PRACTICE AND COMPLIANCE

ABT 740

Identifies and examines the key regulatory agencies and practices that govern the highly regulated and diverse biotechnology industry, both domestically and internationally. Highlights current and emerging FDA and ICH regulations and guidance documents to successfully navigate meeting with the agencies and to submit required documentation for successful product development.