INDUSTRIAL APPLICATIONS IN REGULATORY AFFAIRS

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.

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.

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.

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.

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.