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MLS - Pharmaceutical & Medical Device Law & Compliance

The Master of Legal Studies (MLS) degree with a concentration in Pharmaceutical and Medical Device Law & Compliance was specifically designed for mid-career professionals looking for advancement within or outside their organizations. This 31 credit, online master’s degree exposes students to legal, ethical, and policy issues specific to the life sciences industry and helps students build analytical and communication skills necessary for continued professional development.

All online courses are comprised of week-long modules that allow for one-to-one interaction with professors, and small-group discussions with classmates. Comprehensive, 8-week courses are taken one at a time, so students can devote maximum attention to the subject matter. Professionals graduate in two years on a part-time schedule.

This pharmaceutical law degree is offered through the Seton Hall Law School Center for Health & Pharmaceutical Law, a leading center for research and scholarship. The Center educates lawyers and professionals in the healthcare and life sciences industries regarding the intricate and multifaceted set of laws that govern patients, healthcare providers, manufacturers, and suppliers. The Center at Seton Hall Law School has 15 years of experience delivering superior compliance education to working professionals.

Course options for this concentration are listed below. Contact us using the form at the right for more information or view our admissions requirements here.

Required Courses

  1. Must take all in sequence
  2. All courses are offered ONLINE only
Number Name Credit Offering

HLTH7390

Introduction to Law and Legal Writing

 

This course introduces students to the American legal system and the basic components of legal analysis. Topics covered include:

  1. The structure of the American legal system

  2. The role of statutes, regulations, and judicial decisions

  3. Spotting legal issues, identifying governing rules and principles, and applying the law to different factual situations

  4. Using free Internet resources to locate legal documents and research legal issues

  5. Writing clear and accurate legal summaries and analyses

 

4

online

HLTH7409

Torts: Liability for Civil Wrongs

 

This course examines the law governing private recovery for injuries to person or property, with a particular focus on the law of negligence. Topics include:

  1. The negligence principle

  2. Affirmative duties to act

  3. Duties based on statutory violations

  4. Causation

  5. Defenses to tort liability

  6. Damages

  7. Defamation

This online course examines the law governing private recovery for injuries covered by "civil wrongs."  Focusing on the law of negligence, topics will include determining the standard of care; the roles of judge, jury, custom, and statute; exceptions to the duty to exercise reasonable care; actual and proximate causation; defenses to negligence liability; and damages.  The course will include regular writing assignments designed to strengthen students' analytical and writing skills.  The course is required for students in the MLS program and is not available to students in other degree programs.

3

online

HLTH7400

Fundamentals of Business Law

 

This course introduces students to the law of contracts and to basic principles governing different forms of business associations. Topics include:

  1. The nature and limits of contractual agreements

  2. Contract formation

  3. Defenses to contact enforcement

  4. Remedies for breach of contract

  5. Agency and sole proprietorships

  6. Partnerships

  7. Corporations

  8. Business torts

 

3

online

HLTH7402

Constitutional Law Survey

 

This course provides an overview of the key concepts and legal doctrines underlying the American constitutional structure. Topics covered include:

  1. The Supreme Court’s authority and role

  2. Justiciability and standing

  3. The commerce clause

  4. Separation of powers

  5. Due process and fundamental rights

  6. Equal protection

NOTE: This course is available only to students in the MLS program.

3

online

 

Core Courses

  1. Must take four courses (at least two must be Compliance Issues in the Life Sciences -- Fraud & Corruption, Compliance Issues in the Life Sciences -- Advertising, Promotion and Transparency or FDA Regulation & Liability)
  2. Students may substitute appropriate in-person courses offered at Seton Hall Law School's Newark campus in place of courses listed below with the prior written permission of the Associate Academic Director.
Number Name Credit Offering

HLTH9529

Biotechnology and the Law

 

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

  1. 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

 

3

online

HLTH7685

Clinical Research and the Law: Compliance Issues for Research Sponsors

 

This course examines the responsibilities of life science companies and other entities responsible for the initiation, management, and/or financing of clinical trials in the United States, the European Union, and elsewhere in the world. Topics covered include good clinical practice (GCP) compliance, clinical trial agreements, clinical trial registration and results reporting, access to clinical trial data, managing conflicts of interest, reimbursement issues, and the implications of anti-bribery laws and U.S. fraud and abuse laws for clinical research.

 

3

online

HLTH7680

Clinical Research and the Law: Ethical and Regulatory Issues in Designing Clinical Trials

 

This course immerses students in the laws, regulations, and ethical guidelines applicable to designing clinical research in the United States, the European Union, and elsewhere in the world. Topics covered include an overview of the regulatory framework in the US, the EU, and other regions; the role of international ethical guidelines; ethical and regulatory considerations in choosing a study methodology; informed consent; confidentiality and data protection; the inclusion of women and minorities in clinical research; pediatric research; and post-trial obligations.

 

3

online

HLTH7590

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

 

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. Scientific and educational exchange

  4. Social Media

  5. Constitutional limitations on government regulation of commercial speech

  6. Transparency and disclosure requirements

 

3

online

HLTH7580

Compliance Issues in the Life Sciences - Fraud and Corruption

 

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

  1. The Anti-Kickback Statute

  2. The False Claims Act

  3. The Foreign Corrupt Practices Act and other international anti-bribery legislation

  4. The Racketeer Influenced and Corrupt Organizations Act (RICO)

  5. Enforcement mechanisms

  6. Corporate compliance programs

 

3

online

INDL7550

Cybersecurity and Privacy I: Law & Policy

 

This course provides a broad overview of key issues at the intersection of cybersecurity and privacy. Topics covered include:

  1. Security practices, standards, and insurance

  2. Data breaches, incident response, and corporate governance considerations

  3. Consumer protection law and enforcement actions

  4. The Computer Fraud and Abuse Act (aka the “anti-hacking” statute)

  5. Law enforcement surveillance

  6. Emerging technological paradigms and legislative responses

 

3

online

INDL7555

Cybersecurity and Privacy II: Compliance & Risk Management

 

This course describes practical frameworks for data privacy and security risk management and compliance. We examine the CIA (Confidentiality, Integrity, and Availability) Triad, the NIST Cybersecurity and Privacy Frameworks, and essential principles of Privacy by Design (PbD), along with qualitative and quantitative methods of cyber risk assessment. We apply these frameworks and methods to realistic cybersecurity and privacy scenarios. We further explore methods of transferring cyber risk, including third-party contract terms and cyber insurance. Finally, we discuss legal requirements relating to data breach response and other forms of legal process concerning digital information.

Prerequisite: INDL7550 Cybersecurity I

3

online

CORP7180

EU Data Protection and Privacy Law: The GDPR

 

This course introduces students to the legal regime governing information privacy, data protection, and data security in the European Union. Topics covered include data protection and privacy in the European Court of Human Rights, the Data Protection Directive and the General Data Protection Regulation (GDPR), data protection supervisory authorities and international data transfers, the "right to be forgotten," and cybersecurity in Europe.

 

3

online

HLTH7560

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. The drug and biologic approval processes

  2. The medical device approval and clearance process

  3. Postmarket obligations and pharmacovigilance

  4. Products liability and federal preemption

  5. FDA enforcement

 

3

online

CORP7160

Global Corruption: Regulation, Compliance, and Enforcement

 

This course introduces students to the theory and practice of global anti-corruption compliance. Topics covered include the definition, identification and measurement of corruption; the OECD Convention on Combatting Bribery of Foreign Public Officials; the U.S. Foreign Corrupt Practices Act; the UK Bribery Act; anti-corruption laws in other countries; investigation, enforcement and resolution of corruption activities; jurisdiction, corporate liability and individual responsibility; and anti-corruption compliance programs and international organizational responses.

 

3

online

HLTH7504

HIPAA Privacy and Security

 

This course explores the federal regulatory scheme designed to protect the privacy and security of health information. Topics covered include:

  1. Entities and information to which HIPAA applies

  2. When consent is required for the 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. Business associate agreements

  8. HIPAA compliance and enforcement

 

3

online

 

Elective Courses

  1. Must take two
  2. Can be from any of the concentration areas (including life sciences law courses above)
Number Name

INDL7326

Casinos & Hospitality Law

 

This course will cover the history of casino gaming and the unique legal and compliance issues involved in casino operations. Topics covered will include license applications, management structures, daily operations, anti-money laundering, relationships with manufacturers, distributors, and vendors, premises liability, exclusion lists, player protection, and more.

 

HLTH7524

Children's Health and the Law

 

This course examines the law governing medical treatment of minors, with an emphasis on the tension between parental authority, the child’s needs and wishes, the duty of medical professionals to provide adequate care, and the state’s interest in protecting the child from harm. Topics covered include:

  1. Religious objections to treatment

  2. Mental health and substance abuse treatment

  3. Reproductive healthcare

  4. The withholding or withdrawal of life-sustaining treatment

  5. Medical neglect and medical child abuse

  6. Public health and bioethical issues affecting children

 

INDL7328

Collegiate Athletics Law & Policy

 

This course examines key legal and policy issues related to collegiate athletics, with a focus on the role of the key governing body, the National Collegiate Athletic Association (NCAA).  Topics covered include contemporary issues pertaining to NCAA governance, the NCAA enforcement process, challenges to the NCAA’s amateurism principle, athletes’ ability to profit from the use of their name, image and likeness, employment law issues, sports wagering, and coaches’ contracts.

Coming Summer 2024

HLTH7670

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 Statute, the False Claims Act and the Stark Laws)

  4. Patient safety and quality

  5. Peer review and credentialing processes

  6. Medical error and safety programs

 

LABR7030

Conducting Internal Investigations

 

This course gives you the tools you need to participate in all aspects of internal workplace investigations. Topics covered include:

  1. When companies should (or must) conduct internal investigations

  2. Who should conduct investigations

  3. The role of the investigator

  4. Obtaining cooperation from witnesses

  5. "Adnarim" warnings when attorneys are involved

  6. HR training and development

  7. Privilege and work product issues and their waiver

 

INDL7306

Consumer Data Privacy Law

 

This course examines the complicated and porous scheme of legal privacy protections governing online and offline individual consumer information in the United States. The course will examine topics including:

  1. The role of privacy policies
  2. The Federal Trade Commission’s (FTC) enforcement of privacy violations
  3. Electronic Communications Privacy Act (ECPA) and the Computer Fraud and Abuse Act (CFAA)
  4. Protections for children’s information under the Children ‘s Online Privacy Protection Act (COPAA)
  5. Statutes providing protections against marketing calls and spam
  6. The role of tort lawsuits for individual consumer privacy violations

 

INDL7316

Entertainment Law: Legal Regulation of Industry Practices

 

Entertainment Law 2 examines industry-specific approaches with an eye toward transactional practices, insulation from liability, as well as typical workplace and consumer issues. The course covers contracting practices with respect to the following, among others:

  1. Music royalties
  2. Film actor agreements
  3. Liability waivers for reality television and game shows
  4. Contracts regarding credit, pay or play, and profit participation

It also examines recurrent workplace and social issues in the industry, such as the following:

  1. Race and gender discrimination
  2. Sexual harassment
  3. Censorship

 

INDL7313

Entertainment Law: Torts

 

Entertainment Law 1 provides an introduction to the torts that are frequently encountered in the entertainment business. The course covers topics such as the following:

  1. Law of ideas
  2. Copyright law
  3. Trademark law
  4. Privacy torts
  5. Defamation law
  6. Breach of contract

 

CORP8160

Financial Crimes Compliance

 

This course introduces students to the theory and practice related to financial crimes compliance in the United States, and at the global level. Particular laws examined include: the Money Laundering Control Act, the Bank Secrecy Act, and associated regulations.

At the international level, the course also outlines the work of the Financial Action Task Force and its recommendations on combatting money laundering and terrorism financing.

 

CORP7185

Financial Privacy Law

 

This course explores the federal, state and judicial scheme designed to protect the privacy and security of financial information. Topics covered include:

  1. Regulation of sharing consumer information by financial institutes under the Gramm-Leach Bliley Act.
  2. Regulation of credit reporting agencies under the Fair Credit Reporting Act (FCRA).
  3. Identity theft and businesses’ responsibilities under the Federal Trade Commission’s (FTC) Red Flag Rules.
  4. Protections of individual financial information against the government under the Fourth Amendment and the Right to Financial Privacy Act (RFPA).
  5. State financial privacy law
  6. Breach Notification and Financial Privacy

 

INDL7400

Gaming Law I

 

This course examines laws and regulations that apply to gambling in the United States. Topics covered include definitions of what constitutes gambling; the social, political, and legal history of gambling in the United States; the scope and impact of state regulatory regimes; federal laws that affect the industry; the rise of sports betting; the social consequences of gambling; and tribal gaming.

*Coming Summer 2024

INDL7401

Gaming Law II

 

This course will cover the nature of federalism as it applies to gambling in the United States with a focus on federal statutes that affect gaming. In addition, this course will explore the unique regulatory regimes surrounding Tribal Gaming.

*Coming Summer 2024

CORP7144

Governance, Compliance, Enforcement and Risk Management

 

This course explores corporate governance metrics for complying with federal and state regulatory frameworks, including internal corporate compliance protocols used to fulfill the company’s mission and to minimize risk in the management of the corporation. Topics covered include:

  1. Corporate governance internal protocols

  2. Relationship dynamics between corporate fiduciaries and stakeholders

  3. Development of compliance and risk management policies and procedures

  4. Governmental regulatory compliance frameworks

  5. Attorney’s role in compliance programs

 

HLTH7519

Introduction to Bioethics

 

Introduction to bioethical analysis and application of different bioethical theories to current issues in health care. This course is not focused on legal doctrine per se - it is designed to provide analytical tools to aid in thinking through the ethical dimensions of current legal debates.

*available late 2023

CORP7140

Introduction to Corporate Law

 

This corporate law course examines the organization and operation of business enterprises, with particular emphasis on the corporate form. Topics covered include:

  1. Sole proprietorships

  2. The law of agency

  3. Partnerships

  4. Limited liability companies

  5. The nature of the corporation

  6. Corporate privileges and powers

  7. Rights of shareholders

  8. Powers and fiduciary duties of directors, officers, and controlling shareholders

  9. Derivative lawsuits

 

LABR7000

Managing Legal Issues in the Workplace

 

This course explores the core doctrines that govern the employment relationship. Topics covered include:

  1. Definitions of “employee” and “employer”

  2. The employment-at-will doctrine and its principal exceptions

  3. Employee harassment

  4. Antidiscrimination protections

  5. Health and familial leave protections

  6. Diversity in the workplace

  7. Wage and hour laws

  8. Employee privacy

  9. Liability and litigation risk management

 

INDL7333

Professional Sports Law & Policy

PUBR7905

Race and the Foundations of American Law

 

This course illuminates the way racial hierarchy has played a role in the development of American law. It examines the historical origins of racial hierarchy beginning in the colonial period and continues that examination through modern legal doctrine. Students will evaluate the continuing impact of the history of white supremacy in areas such as housing, law enforcement, and education. The course concludes with an analysis and critique of some current efforts to repair the harms that have been created by racial hierarchy.

 

INDL7336

Sports Betting & Fantasy Sports

 

This course will cover the history and regulation of sports betting and fantasy sports both before and after 2018. Topics covered will include the limits on sports betting prior to the repeal of the Professional and Amateur Sports Protection Act ("PASPA"), the constitutional challenge to PASPA, and the expansion of sports betting in the United States after PASPA was repealed. In addition, this course will address gaming as it relates to both fantasy sports and esports.

*Coming Summer 2024

HLTH7690

Stark Law and Compliance

 

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

 

HLTH7660

The Law of Patient Care

 

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

  1. The formation and termination of the provider-patient relationship

  2. The Emergency Medical Treatment and Active Labor Act (EMTALA)

  3. Medical malpractice

  4. Informed consent

  5. Medical confidentiality (including HIPAA compliance)

  6. Treatment decisions for patients who lack decision-making capacity

  7. Treatment decisions for children and adolescents

  8. Mental health treatment

 

INDL7332

Title IX and Gender Equity in Sports

LABR7600

Workplace Privacy Law

 

This course examines the modern realities of privacy in the workplace, covering the kinds of personal information an employer may want to learn about an employee, or prospective employee, as well as the kinds of monitoring an employer may conduct in relation to employees: email monitoring, social media monitoring, drug testing, and even DNA testing. Attention is paid to the use of new technologies, including digital technologies and biotechnological advances, that enable new forms of incursion into employee privacy. The course surveys the current patchwork of American laws that apply to workplace privacy, including principles of constitutional law, tort law, contract law and federal statutes that protect employee privacy. Some comparison is made with laws in other countries, specifically countries of the European Union, as these laws are increasingly relevant to organizations that operate across national borders.

 

 

Division of Online Learning

[email protected] | 973-642-8747 or 973-761-9000 ext. 8747