Bioengineering

  1. Professional and Ethical Considerations
    1. Bioethics
      1. Human Subjects in Research
        1. Institutional Review Boards
          1. IRB Composition
            1. Review Process
              1. Continuing Review
              2. Risk-Benefit Analysis
                1. Risk Assessment
                  1. Benefit Evaluation
                    1. Risk Minimization
                  2. Animal Subjects in Research
                    1. Animal Welfare Regulations
                      1. Institutional Animal Care and Use Committees
                        1. Animal Welfare Act
                          1. Guide for Care and Use
                          2. Ethical Use of Animals
                            1. Three Rs Principle
                              1. Alternatives to Animal Testing
                                1. Humane Endpoints
                              2. Genetic Engineering Ethics
                                1. Germline Editing
                                  1. Heritable Modifications
                                    1. Ethical Concerns
                                      1. International Guidelines
                                      2. Cloning
                                        1. Reproductive Cloning
                                          1. Therapeutic Cloning
                                            1. Ethical Debates
                                            2. Dual-Use Research
                                              1. Research Oversight
                                                1. Publication Guidelines
                                                  1. Security Considerations
                                                2. Data Privacy in Genomics
                                                  1. Genetic Data Security
                                                    1. Data Encryption
                                                      1. Access Controls
                                                        1. Breach Prevention
                                                        2. Ethical Data Sharing
                                                          1. Data Anonymization
                                                            1. International Collaboration
                                                        3. Regulatory Affairs
                                                          1. Food and Drug Administration
                                                            1. Device Approval Pathways
                                                              1. 510(k) Clearance
                                                                1. Premarket Approval
                                                                  1. De Novo Classification
                                                                  2. Drug Approval Process
                                                                    1. Investigational New Drug Application
                                                                      1. New Drug Application
                                                                        1. Biologics License Application
                                                                      2. Environmental Protection Agency
                                                                        1. Environmental Regulations for Biotech
                                                                          1. Toxic Substances Control Act
                                                                            1. Federal Insecticide Act
                                                                              1. Biotechnology Regulations
                                                                            2. Medical Device Classification
                                                                              1. Device Classes and Risk Levels
                                                                                1. Class I Devices
                                                                                  1. Class II Devices
                                                                                    1. Class III Devices
                                                                                    2. Regulatory Requirements
                                                                                      1. Quality System Regulation
                                                                                        1. Medical Device Reporting
                                                                                          1. Labeling Requirements
                                                                                        2. Clinical Trials Process
                                                                                          1. Phases of Clinical Trials
                                                                                            1. Phase I Trials
                                                                                              1. Phase II Trials
                                                                                                1. Phase III Trials
                                                                                                  1. Phase IV Trials
                                                                                                  2. Good Clinical Practice
                                                                                                    1. Protocol Development
                                                                                                      1. Data Integrity
                                                                                                        1. Regulatory Compliance
                                                                                                    2. Intellectual Property
                                                                                                      1. Patents in Biotechnology
                                                                                                        1. Patentability Criteria
                                                                                                          1. Novelty
                                                                                                            1. Non-obviousness
                                                                                                              1. Utility
                                                                                                              2. Patent Application Process
                                                                                                                1. Application Preparation
                                                                                                                  1. Prosecution
                                                                                                                2. Trademarks
                                                                                                                  1. Trademark Protection
                                                                                                                    1. Registration Process
                                                                                                                      1. Enforcement
                                                                                                                      2. Trade Secrets
                                                                                                                        1. Protection Strategies
                                                                                                                          1. Confidentiality Agreements
                                                                                                                            1. Employee Training
                                                                                                                              1. Physical Security

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                                                                                                                        4. Major Application Areas in Bioengineering

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                                                                                                                        1. Foundations of Bioengineering