ETHICS, SAFETY, AND REGULATORY ENVIRONMENTS IN BIOTECHNOLOGY

Name: ETHICS, SAFETY, AND REGULATORY ENVIRONMENTS IN BIOTECHNOLOGY
Availability: OutOfStock
Rating: 4.7 (126 reviews)

ABT 705

과목 설명

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.

선수과목

Declared in Applied Biotechnology program

충족 요건

ABT 745 , ABT 740 , and ABT 735

학점

미보고

개설 시기

미보고

평점

3.79

1% 과거 데이터 대비

수료율

100%

과거 데이터 대비 변화 없음

A 비율

83.33%

26.51% 과거 데이터 대비

학급 규모

-14.29% 과거 데이터 대비

Cumulative Grade Distribution

강사 (2026 Summr)

다음 사이트의 평점순으로 정렬 Rate My Professors

유사 과목

INDUSTRIAL APPLICATIONS IN REGULATORY AFFAIRS

ABT 745

Examines regulatory environments in risk-based assessment of biotechnological developments in industry, agriculture, and probiotics ensuring consumer and environmental protection. Addresses how validation is essential to the incorporation of emerging technologies into viable, accessible, and successful products. Highlights the stakeholders' role in regulatory oversight and policy through relevant industry case studies.

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.

BIOTECHNOLOGY REGULATION AND ETHICS

BIOMDSCI 801

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.

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.