Biomedical Sciences and Technologies (BIOMDSCI) < University of Wisconsin-Madison

BIOMDSCI 720 — SURVEY OF QUALITY ASSURANCE AND REGULATORY AFFAIRS IN BIOTECHNOLOGY

3 credits.

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.

Requisites: Declared in the Capstone Certificate in Quality Assurance and Regulatory Affairs in Biotechnology

Course Designation: Grad 50% - Counts toward 50% graduate coursework requirement

Repeatable for Credit: No

Learning Outcomes: 1. Recognize, foster, and apply principles of ethical and professional conduct.
Audience: Graduate

2. Describe local, national, and international agencies involved in ensuring quality and safety.
Audience: Graduate

3. Integrate how testing and manufacturing relies upon regulatory requirements.
Audience: Graduate

4. Demonstrate effective listening, written, verbal, and nonverbal communication skills.
Audience: Graduate

5. Analyze product development and project management innovations in terms of quality assurance and regulatory compliance requirements.
Audience: Graduate

BIOMDSCI 721 — TOPICS IN QUALITY ASSURANCE AND REGULATORY AFFAIRS IN BIOTECHNOLOGY

3 credits.

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.

Requisites: Declared in the Capstone Certificate in Quality Assurance and Regulatory Affairs in Biotechnology

Course Designation: Grad 50% - Counts toward 50% graduate coursework requirement

Repeatable for Credit: No

Learning Outcomes: 1. Evaluate quality systems used in product development and commercialization of medical devices.
Audience: Graduate

2. Influence medical device development and project vision from quality assurance and regulatory affairs standpoints.
Audience: Graduate

3. Produce quality and regulatory strategies to achieve organizational objectives of medical devices.
Audience: Graduate

4. Compose effective communication with colleagues, customers, and regulatory agencies.
Audience: Graduate

5. Troubleshoot design and manufacturing issues of medical device development to meet regulatory standards.
Audience: Graduate

6. Monitor how diverse teams fit into organizational culture and successfully contribute towards product development.
Audience: Graduate

BIOMDSCI 722 — LEADERSHIP IN QUALITY ASSURANCE AND REGULATORY AFFAIRS IN BIOTECHNOLOGY

3 credits.

Leaders in the Quality Assurance and Regulatory Affairs departments influence and facilitate bringing products to market within the biotechnology industry. Focus on building communication among cross functional teams; exercising writing to specific audiences; and meeting internal and external customer needs and expectations. Explore and apply how quality and regulatory affairs skills are managed within diverse product and project teams.

Requisites: Declared in the Capstone Certificate in Quality Assurance and Regulatory Affairs in Biotechnology

Course Designation: Grad 50% - Counts toward 50% graduate coursework requirement

Repeatable for Credit: No

Learning Outcomes: 1. Influence product and project vision from quality assurance and regulatory affairs standpoints.
Audience: Graduate

2. Develop strategies to achieve organizational objectives.
Audience: Graduate

3. Communicate effectively with colleagues, customers, and regulatory bodies.
Audience: Graduate

4. Illustrate leadership principles and use ethical behavior in challenging and ambiguous situations.
Audience: Graduate

5. Practice how diverse teams fit into organizational culture and successfully contribute from product development through submission, product launch, and post-market surveillance.
Audience: Graduate

BIOMDSCI 800 — INTELLECTUAL PROPERTY, PATENTS AND LICENSING

2 credits.

Explore core concepts of how intellectual property, patent law, trademarks, copyrights, trade secrets, licensing and patent litigation specifically relate to the field of biotechnology. Evaluate how types of intellectual property work to protect a product or service. Explain the importance of patents in terms of licensing and technology transfer. Assess the unique aspects of early-stage intellectual property, including how it pertains to market dynamics, pricing and valuation.

BIOMDSCI 801 — BIOTECHNOLOGY REGULATION AND ETHICS

2 credits.

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.

BIOMDSCI 802 — BUSINESS OF BIOTECHNOLOGY: BUSINESS FUNDAMENTALS

2 credits.

Discover the business challenges inherent in translating scientific discoveries into a successful business. Apply fundamental business principles that guide the operations of biotechnology companies.

BIOMDSCI 803 — MOLECULAR TECHNOLOGIES I: DIAGNOSTIC TESTING

2 credits.

Assess various biotechnology techniques to determine effective and efficient methods used in biotechnology product development. Utilize analytical and communication skills when critiquing biotechnology applications that simulate both corporate and academic biotechnology settings.

BIOMDSCI 810 — BIOTECHNOLOGY OPERATIONS

4 credits.

Explore the six operational specialties of product development: Regulatory; Quality Assurance; Biomanufacturing; Quality Control; Nonclinical Development; and Clinical Development. Expand upon leadership skills by implementing biotechnology operation plans that successfully bring new products to market.

BIOMDSCI 812 — PROJECT MANAGEMENT AND LEADERSHIP

2 credits.

Practice developing, modifying, and maintaining project management plans within the biotechnology and medical device industries. Hone leadership skills and experience by working among diverse teams and addressing situations faced by Project Managers.

BIOMDSCI 813 — MOLECULAR TECHNOLOGIES II: BIOMANUFACTURING

2 credits.

Develop, create, and present scientific poster presentation. Utilize and assess multiple technology platforms used in biomanufacturing. Develop and critique batch records used in biomanufacturing and bio-engineering environments.

BIOMDSCI 820 — EARLY DRUG DISCOVERY

4 credits.

Examine the early drug discovery process, including target identification and validation, generation of diverse chemical libraries, assay development and high throughput screening, lead optimization by compound profiling, and drug targeting and delivery.

BIOMDSCI 822 — BUSINESS OF BIOTECHNOLOGY: COMMERCIALIZATION PATHWAYS

2 credits.

Explore contemporary issues in the business of biotechnology and apply concepts critical to the success of modern biotechnology firms. Focus on modern problem-solving topics, including issues relating to corporate leadership, fundings sources for product development, customer identification, financial accounting management, and negotiation.

BIOMDSCI 823 — MOLECULAR TECHNOLOGIES III: ASSAY DEVELOPMENT

2 credits.

Evaluate laboratory assays and methods used in primary, secondary, and in vitro ADMETox (Absorption, Distribution, Metabolism, Excretion, Toxicity) drug screening. Build scientific communication and critical thinking skills while working on team projects and analyzing scientific results.

BIOMDSCI 830 — PROFESSIONAL DEVELOPMENT AND EFFECTIVE MANAGEMENT

1 credit.

Focus on effective management and career development techniques that lead to career success. Practice and apply skills needed to effectively lead synergistic team success within a biotechnology company. Explore different communication styles used to engage and assess employees. Expand career pathways through networking and by generating professional resumes and interviewing skills.

BIOMDSCI 831 — ADVANCED BIOTECHNOLOGY: GLOBAL PERSPECTIVES

3 credits.

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.

BIOMDSCI 832 — BUSINESS OF BIOTECHNOLOGY: CORPORATE STRATEGY

3 credits.

Examine how companies gain and sustain competitive advantages by utilizing business tools, methods, and strategies. Critique how company leaders make decisions under uncertainty. Integrate the knowledge and skills gained from prior studies (e.g., marketing, management, finance, accounting) to apply synergistic responses and insights when developing company-wide strategy.

BIOMDSCI 834 — BIOTECHNOLOGY CAPSTONE

1 credit.

Identify a global biotechnology problem, find a novel technical solution, analyze all aspects from a business, regulatory, and intellectual property perspective, and deliver a final written capstone thesis.