Graduate Certificate Programs

Division of Online Learning

Seton Hall Law offers four 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 four Online Graduate Certificate program choices are:

  1. Pharmaceutical and Medical Device Law and Compliance
  2. Health and Hospital Law
  3. Intellectual Property Law
  4. Human Resources 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, or a combination of two courses in a related area and an elective.

Pharmaceutical and Medical Device Law and Compliance

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 three courses. Each course takes eight weeks to complete, and you may take them in any order you choose.

The courses offered are:

FDA Regulation and Liability
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. Topics covered include:

  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

Clinical Research and the Law
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

Compliance Issues in the Life Sciences
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. Enforcement mechanisms
  5. Corporate compliance programs
  6. Transparency and disclosure requirements

Health and Hospital Law

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 three courses. 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
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

Compliance Issues for Healthcare Providers
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

Clinical Research and the Law
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

Law of Death & Dying
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

Intellectual Property Law

Protecting brands, inventions, and original works is essential in almost any industry. Our intellectual property 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. Each course takes eight weeks to complete, and you may take them in any order you choose.

The courses offered are:

Patent & Trade Secrets Law
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

Trademark & Unfair Competition Law
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

Copyright Law
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

Human Resources Law

The activities associated with human resources for any company can be complex. While not intended to substitute for legal advice, this program is ideal if you are a human resources professional and would like to enhance your knowledge of the legal influences that you must consider on a day-to-day basis. A Certificate in Human Resources Law can be completed in 24 weeks and will be awarded upon completion of three courses. Each course takes eight weeks to complete, and you may take them in any order you choose.

The courses offered are:

Core Legal Issues in the Workplace
The materials throughout this course focus on application of legal concepts to real-world circumstances and the role of the human resources professional in addressing legal compliance and reducing legal risks. Topics covered include:

  1. Employment at-will doctrine and its contract and tort-based limitations
  2. Employee harassment
  3. Definitions of “employee” and “employer”
  4. Antidiscrimination protections
  5. Health and familial leave protections
  6. Diversity
  7. Wage and hour laws
  8. Employee privacy, and liability and litigation risk management.

Conducting Legal Investigations in the Modern Workplace
This course provides an in-depth treatment of workplace employee investigations by providing in-depth workplace investigation training. This includes who should conduct the investigation, how it should be conducted, and potential outcomes, including retaliation. Topics include:

  1. Role of the investigator
  2. Obtaining cooperation from witnesses
  3. “Adnarim” warnings when attorneys are involved
  4. HR training and development
  5. Privilege and work product issues and their waiver
  6. Whether to record investigations verbatim, etc.

Managing Whistleblower Risks
This course explores the vast array of federal and state laws that protect employees who report misconduct by their employers. Although the focus is not limited to the healthcare industry, examples of healthcare-related whistleblower cases are examined throughout the course. Topics covered include:

  1. Common-law whistleblower protections
  2. State and federal whistleblower statutes
  3. Strategies for managing whistleblowers and whistleblowing
  4. Role of the human resources professional in the whistleblower management process.

Online Graduate Certificate Programs At-A-Glance


CERTIFICATE IN PHARMACEUTICAL & MEDICAL DEVICE LAW &
COMPLIANCE

Length of Program

FDA Regulation & Liability
8 weeks

Compliance Issues in the Life Sciences
8 weeks

Clinical Research & the Law
8 weeks

CERTIFICATE in Pharmaceutical & Medical Device Law & Compliance

24 weeks
CERTIFICATE IN HEALTH & HOSPITAL LAW
Length of Program

The Law of Patient Care
8 weeks

Compliance Issues for Healthcare Providers
8 weeks

Clinical Research & the Law
8 weeks

Law of Death & Dying

8 weeks

CERTIFICATE in Health & Hospital Law

24 weeks
CERTIFICATE IN INTELLECTUAL PROPERTY LAW
Length of Program

Patent & Trade Secret Law
8 weeks

Trademark & Unfair Competition Law
8 weeks

Copyright Law
8 weeks

CERTIFICATE in Intellectual Property Law

24 weeks
CERTIFICATE IN HUMAN RESOURCES LAW
Length of Program

Core Legal Issues in the Workplace
8 weeks

Conducting Legal Investigations in the Modern Workplace
8 weeks

Managing Whistleblower Risks
8 weeks

CERTIFICATE in Human Resources Law

24 weeks

 


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