INDUSTRIAL APPLICATIONS IN REGULATORY AFFAIRS

Name: INDUSTRIAL APPLICATIONS IN REGULATORY AFFAIRS
Availability: OutOfStock

ABT 745

과목 설명

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.

선수과목

ABT 700 , ABT 705 , and ABT 710

충족 요건

This course does not satisfy any prerequisites.

학점

미보고

개설 시기

미보고

평점

3.75

4.43% 과거 데이터 대비

수료율

100%

과거 데이터 대비 변화 없음

A 비율

66.67%

46.67% 과거 데이터 대비

학급 규모

118.18% 과거 데이터 대비

Cumulative Grade Distribution

강사 (2026 Summr)

다음 사이트의 평점순으로 정렬 Rate My Professors

유사 과목

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.

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.

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.

ASSESSING INNOVATION IN BIOTECHNOLOGY

ABT 765

A survey of biotechnology assessments in areas such as regenerative medicine, agricultural biotechnology, and bioremediation. Course links disciplines with the critical evaluative role played by scientific discovery, market valuation, intellectual property, freedom-to-operate (FTO), and licensing strategy by assessing the role each played in the commercialization of a specific technology.

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.