Graduate Certificate Programs

Division of Online Learning

Seton Hall Law offers three online law programs designed specifically for professionals who work in highly regulated fields. The programs are delivered online and can be completed in 24 weeks. Each program is divided into three eight-week segments. The three Online Graduate Certificate program choices are:

  1. Pharmaceutical & Medical Device Law & Compliance
  2. Health & Hospital Law
  3. Intellectual Property Law

The online format offers flexibility for individuals who have commitments that make it difficult for them to attend classes on campus. The certificate courses are taught by the same instructors who teach at the Seton Hall Law campus.

Interested students may enroll in individual courses to obtain CLE or CEU credit; however, a certificate will not be awarded until three courses have been completed. Three courses in one area satisfy the certificate requirement.

Certificate in Pharmaceutical & Medical Device Law & Compliance | 24 Weeks

This program is ideal if you work in compliance, legal, regulatory and medical affairs, sales, marketing, grants, and related areas in the pharmaceutical and medical device industries. A Certificate in Pharmaceutical & Medical Device Law & Compliance can be completed in 24 weeks and will be awarded upon completion of any three courses listed below. Each course takes eight weeks to complete, and you may take them in any order you choose.

The courses offered are:

FDA Regulation & Liability | 8 Weeks

This course explores the FDA's extensive regulation of the pharmaceutical and medical device industries, as well the relationship between FDA regulation and state-law tort liability. FDA Regulation and Liability online law courses cover the following:

  1. FDA approval process
  2. Pharmacovigilance
  3. Products liability and FDA preemption
  4. FDA oversight of advertising and promotion
  5. Life science companies and the First Amendment

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Clinical Research & the Law | 8 Weeks

This course explores regulatory, ethical, and compliance issues that arise for individuals and entities involved in all aspects of clinical trials, including sponsors, researchers, research institutions, contract research organizations, and institutional review boards. Topics covered include:

  1. IRB review
  2. Risk-benefit assessment
  3. Informed consent
  4. Confidentiality and HIPAA compliance
  5. Conflicts of interest
  6. Inclusion of women and minorities in clinical research
  7. Pediatric research

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Compliance Issues in the Life Sciences - Advertising, Promotion and Transparency | 8 Weeks

This course provides an overview of the laws, regulations, guidances and enforcement actions related to the advertising and promotion of prescription drugs and medical devices. Topics covered include:

  1. Direct-to-consumer advertising
  2. Off-label promotion
  3. Self-regulation
  4. Social Media tools for drug and device marketing
  5. First Amendment protections
  6. Transparency and disclosure requirements

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Compliance Issues in the Life Sciences - Fraud and Corruption | 8 Weeks

This course examines life science companies' obligations under laws designed to detect and respond to bribery, fraud, waste, and abuse. Topics covered include:

  1. Anti-Kickback Act
  2. False Claims Act
  3. Foreign Corrupt Practices Act and other international anti-bribery legislation
  4. Racketeer Influenced and Corrupt Organizations Act (RICO)
  5. Enforcement mechanisms
  6. Corporate compliance programs

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Biotechnology and the Law | 8 Weeks

This course examines a variety of legal, policy, scientific, social, and ethical issues in the realm of biotechnology. Topics covered include:

  1. Examination of foundational technologies such as recombinant DNA technology
  2. Current applications, including nanobiotechnology and synthetic biology
  3. Human subjects research and institutional review of clinical trials
  4. Regulatory oversight by federal agencies
  5. Academic-industry relationships
  6. Data, privacy, and security issues
  7. Protection of intellectual property

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HIPAA Privacy & Security | 8 Weeks

This course explores the federal law that is designed to protect the privacy and security of health information - the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Topics covered include:

  1. Entities and information to which HIPAA applies
  2. When consent is required for use and disclosure of health information
  3. Types of health information requiring heightened protection
  4. Use of health information for research and marketing
  5. Security measures required to protect digitized health information
  6. Individuals’ right to access their health information
  7. Enforcement and compliance with HIPAA’s requirements

Learn more »


Certificate in Health & Hospital Law | 24 Weeks

This program is ideal if you are a lawyer transitioning to the healthcare industry. Hospital administrators and compliance officers, physicians, nurses, and other healthcare professionals, state and federal regulators, and patient advocates also benefit from the material. The graduate certificate in Health and Hospital Law is designed for professionals seeking to enhance their knowledge of legal, regulatory, and ethical issues related to the delivery of healthcare. A Certificate in Health & Hospital Law can be completed in 24 weeks and will be awarded upon completion of any three courses listed below. Each course takes eight weeks to complete, and you may take them in any order you choose.

The courses offered are:

The Law of Patient Care | 8 Weeks

This course gives students an overview of key legal, ethical, and regulatory issues related to the provision of medical care. Topics covered include:

  1. Formation and termination of the physician-patient relationship
  2. Emergency Medical Treatment and Active Labor Act (EMTALA)
  3. Medical malpractice
  4. Informed consent
  5. Medical confidentiality (including the HIPAA Privacy Rule)
  6. Treatment decisions for patients who lack decision-making capacity
  7. Treatment decisions for children and adolescents
  8. Mental health treatment

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Compliance Issues for Healthcare Providers | 8 Weeks

This course introduces students to the primary areas of law that impose compliance obligations on healthcare providers. Topics covered include:

  1. Nonprofit corporation law
  2. Laws governing state and federal tax exemptions
  3. Federal fraud and abuse laws (including the Anti-Kickback Law, the False Claims Act and the Stark Law)
  4. Patient safety and quality
  5. IRS requirements for nonprofit hospitals
  6. Peer review and credentialing processes
  7. Medical error and safety programs

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Clinical Research & the Law | 8 Weeks

This course explores regulatory, ethical, and compliance issues that arise for individuals and entities involved in all aspects of clinical trials, including sponsors, researchers, research institutions, contract research organizations, and institutional review boards. Topics covered include:

  1. IRB review
  2. Risk-benefit assessment
  3. Informed consent
  4. Confidentiality and HIPAA compliance
  5. Conflicts of interest
  6. Inclusion of women and minorities in clinical research
  7. Pediatric research

Learn more »

The Law of End-of-Life Decision-Making | 8 Weeks

This course explores legal, ethical and public policy issues related to end-of-life medical care. Topics covered include:

  1. Cost of end-of-life care
  2. Supreme Court end-of-life jurisprudence
  3. Advance directives and POLST
  4. Minimally conscious state
  5. Challenges at the beginning of life
  6. Physician-assisted suicide

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Children's Health and the Law | 8 Weeks

This course examines the law governing medical treatment of minors. It explores the tension between parents’ authority to make decisions on behalf of the child, the child’s needs and wishes, the duty of medical professionals to provide adequate care, and the state’s interest in protecting the child and citizens from harm. Topics covered include:

  1. How medical decisions are made or should be made when there is disagreement about the appropriate course of treatment
  2. Religious objections to treatment
  3. Traditional versus alternative treatment options
  4. Issues raised when minors wish to make decisions about their reproductive health
  5. Challenges raised when a minor needs mental health treatment
  6. Public health issues affecting children

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HIPAA Privacy & Security | 8 Weeks

This course explores the federal law that is designed to protect the privacy and security of health information - the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Topics covered include:

  1. Entities and information to which HIPAA applies
  2. When consent is required for use and disclosure of health information
  3. Types of health information requiring heightened protection
  4. Use of health information for research and marketing
  5. Security measures required to protect digitized health information
  6. Individuals’ right to access their health information
  7. Enforcement and compliance with HIPAA’s requirements

Learn more »

Stark Law & Compliance | 8 Weeks

This course provides an opportunity to explore, in-depth, the federal physician self-referral prohibition, known as the Stark Law. Topics covered include:

  1. Key elements of the Stark Law
  2. Regulatory exceptions to the Stark Law
  3. Identification of non-compliance
  4. Implications of Stark Law violations
  5. Mitigating risk of legal exposure under Stark
  6. Structuring compliant physician relationships

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Certificate in Intellectual Property Law | 24 Weeks

Protecting brands, inventions, and original works is essential in almost any industry. Our intellectual property online law courses provide an intensive exposure to the patent rights, trademark, trade secrets, and copyright protection laws. Entrepreneurs will find the information covered beneficial. A Certificate in Intellectual Property Law can be completed in 24 weeks and will be awarded upon completion of three courses. Two of the three courses must be Copyright Law, Patent & Trade Secret Law, or Trademark & Unfair Competition Law.  Each course takes eight weeks to complete, and you may take them in any order you choose.

The courses offered are:

Patent & Trade Secret Law | 8 Weeks

This course provides an overview of the basic doctrines of patent law, as well as related rights such as trade secret law and drug law exclusivity under the Hatch-Waxman Act. Topics covered within our patent law programs include:

  1. Standards and procedures for obtaining patent protection
  2. Patent infringement litigation
  3. Relationship between patent protection and trade secret law
  4. Role of patent law and litigation in the pharmaceutical industry

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Trademark & Unfair Competition Law | 8 Weeks

This course explores common law and statutory protection of ideas, trade secrets, and trademarks. Topics covered include:

  1. Acquisition and loss of trademark rights
  2. Registration and licensing
  3. Problems of infringement, dilution, and misappropriation of trademarks
  4. Fair use and Internet use of trademarks and related remedies

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Copyright Law | 8 Weeks

The Copyright Law course is intended for people who work in an IP law field and those with a more general interest in the area. No specialized scientific knowledge is required. Topics covered include:

  1. Overview of the basic doctrines of copyright law
  2. Creation and dissemination of expressive information, artistic creations, and innovative works, including software, architecture, and databases
  3. Development of legal research and writing skills

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Cybersecurity & Privacy: Law, Policy, Compliance | 8 Weeks

This course examines the law and policy of foreign and domestic Internet governance. Topics covered include:

  1. Risks to cybersecurity from mismanagement, crime, terrorism, and war
  2. Online privacy and personal data protection
  3. Private infrastructure and the Law of Emergencies
  4. Emerging compliance frameworks for cybersecurity

Learn more »

Biotechnology and the Law | 8 Weeks

This course examines a variety of legal, policy, scientific, social, and ethical issues in the realm of biotechnology. Topics covered include:

  1. Examination of foundational technologies such as recombinant DNA technology
  2. Current applications, including nanobiotechnology and synthetic biology
  3. Human subjects research and institutional review of clinical trials
  4. Regulatory oversight by federal agencies
  5. Academic-industry relationships
  6. Data, privacy, and security issues
  7. Protection of intellectual property

Learn more »

HIPAA Privacy & Security | 8 Weeks

This course explores the federal law that is designed to protect the privacy and security of health information - the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Topics covered include:

  1. Entities and information to which HIPAA applies
  2. When consent is required for use and disclosure of health information
  3. Types of health information requiring heightened protection
  4. Use of health information for research and marketing
  5. Security measures required to protect digitized health information
  6. Individuals’ right to access their health information
  7. Enforcement and compliance with HIPAA’s requirements

Learn more »



 



Master of Science in Jurisprudence Online Degree | Open House - October 24, 2015




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