BMEG-E 503 Biomedical Ethics and Regulation
3 credits
- Prerequisite(s): None
- Delivery: On-Campus
Description
This course covers management, economic, policy, and ethical issues in pharmaceutical, biotechnology, and medical device industries. Topics include R&D regulations, FDA approval, mergers, liability, and ethics in drug delivery, health technology, bio-nanotechnology, tissue engineering, and implants. Students examine industry challenges, regulations, and how decisions impact innovation and public health.
Topics
Introduction to the biomedical industry
- Overview of pharmaceuticals, biotechnology, and medical devices
- Industry structure and key players
- Challenges and trends in biomedical innovation
Regulatory frameworks in healthcare
- U.S. regulatory bodies: FDA, CDC, and NIH
- International regulatory agencies and harmonization
- Overview of drug and medical device approval processes
Research and development in healthcare
- Phases of drug and device development
- Preclinical testing and clinical trials
- R&D costs, risks, and impact on innovation
FDA regulatory process
- Good manufacturing practices and compliance
- Clinical trial design, phases, and ethical considerations
- Post-market surveillance and adverse event reporting
Economic factors in healthcare
- Drug pricing and reimbursement model
- Market dynamics and economic barriers
- Accessibility and affordability of healthcare technologies
Mergers and acquisitions in biomedical industries
- Trends in consolidation and industry impact
- Strategic motivations and regulatory implications
- Case studies of recent mergers in pharmaceuticals and biotech
Bioethics in pharmaceuticals and biotechnology
- Ethical frameworks and patient rights
- Issues in clinical trials and informed consent
- Ethical challenges in biotechnology and genetic research
Ethics in emerging health technologies
- Ethical issues in bio-nanotechnology and tissue engineering
- Privacy and data security in biomedical innovations
- Impacts of emerging technologies on society and healthcare equity
Liability and risk management in biomedical industries
- Legal aspects of liability in drug delivery and device usage
- Risk management strategies for manufacturers
- Regulatory considerations and industry standards for safety
Public health implications of biomedical innovation
- Impact of healthcare innovations on public health
- Policy implications and social equity in healthcare
- Case studies of innovation impact on specific populations
Technological advancements in healthcare
- Overview of AI, nanotechnology, and bioprinting in medicine
- Applications and limitations of advanced technologies
- Ethical and regulatory challenges in emerging tech
Biomedical data analysis
- Data handling and privacy concerns in healthcare
- Statistical and computational tools for biomedical data
- Applications of big data in patient care and medical research
Compliance management in healthcare
- Strategies for managing regulatory compliance
- Compliance in clinical trials and manufacturing
- Role of compliance in risk management and public safety
Ethical decision-making and public perception
- Influence of ethics on public acceptance of biotechnology
- Case studies of ethical decision-making in industry
- Media’s role in shaping perceptions of health technologies
Future trends and challenges in biomedical industries
- Predicting shifts in pharmaceutical and biotech industries
- Emerging policy and regulatory challenges
- Sustainability and global health equity in biomedical innovation
Learning Outcomes
- Analyze the regulatory frameworks governing drug and medical device approvals in the U.S. and internationally.
- Evaluate ethical challenges in biotechnology and pharmaceutical development, including issues in clinical trials and patient rights.
- Design strategies for managing mergers and acquisitions within the biomedical industry, considering regulatory and financial impacts.
- Analyze the economic factors influencing the pricing and accessibility of pharmaceuticals and medical devices.
- Evaluate the implications of new health technologies, such as bio-nanotechnology and tissue engineering, on public health policy.
- Write policies that address liability concerns in drug delivery and medical device usage.
- Evaluate the role of innovation in healthcare to address emerging industry challenges and regulatory constraints.
- Analyze the influence of ethical decision-making on public perception and acceptance of biotechnology products.
- Write comprehensive proposals for managing compliance within health technology, biotechnology, and pharmaceutical sectors.
Policies and Procedures
Please be aware of the following linked policies and procedures. Note that in individual courses instructors will have stipulations specific to their course.