A regulatory affairs degree focused specifically on the life sciences industry.
Students who complete this 31-credit, regulatory compliance degree graduate with a
comprehensive understanding of the legal, ethical, and policy issues specific to pharmaceuticals,
biologics, and medical devices, and the analytical and communication skills essential
for career advancement.
The Master of Legal Studies (MLS) degree with a concentration in Pharmaceutical and
Medical Device Law & Compliance at Seton Hall Law School is designed for professionals
seeking to deepen their understanding of the legal and regulatory frameworks governing
the life sciences industry.
Students delve into specialized subjects through courses tailored to the life sciences
sector. These include biotechnology law, compliance issues for research sponsors,
ethical and regulatory considerations in clinical trials, advertising and promotion
regulations, and fraud and corruption in the industry. This life sciences law coursework
ensures that graduates are well-versed in the legal challenges and compliance requirements
unique to the pharmaceutical and medical device fields, making them valuable assets
in roles that demand expertise in regulatory compliance.
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 more than 20 years of experience delivering
exceptional healthcare compliance education to working professionals.
Course Requirements
Course requirements for this degree are listed below. Contact us using the form on
this page if you have additional questions or view our admissions requirements here.
Required Courses
Must take all in sequence. All courses are offered ONLINE only.
Introduction to Law and Legal Writing
Students will learn to:
Identify relevant facts, legal issues, rules of law, and holdings in judicial decisions
Assess and apply statutes, regulations, and the common law to select issues
Convert legal research and analysis into a precise, accurate, and readable written
product
Torts: Liability for Civil Wrongs
Students will learn to:
Explain the basic principles underlying the law of negligence
Recognize the factors courts consider in determining the causes of a particular outcome
Evaluate how a victim’s contribution to his or her injury may affect the determination
of liability or damages
Fundamentals of Business Law
Students will learn to:
Explain the basic elements of enforceable contracts
Recognize the circumstances in which courts will refuse to honor particular agreements
Evaluate the advantages and disadvantages of different types of business associations
Constitutional Law Survey
Students will learn to:
Explain the role of the Supreme Court in interpreting and enforcing the U.S. Constitution
Identify the circumstances in which individuals and organizations can obtain judicial
review of potential constitutional violations
Assess the implications of the due process clause for laws and policies that affect
intimate decisions
Evaluate the Supreme Court’s approach to laws that have the purpose or effect of discriminating
against individuals on the basis of race, gender, or other characteristics
Core Courses
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)
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.
Biotechnology and the Law
Students will learn to:
Interpret relevant statutes, case law, and regulations pertaining to biotechnology
Assess incentives for innovation, such as federal funding, licensing, and patents
Evaluate ethical considerations related to biotechnology and the mechanisms that exist
for addressing them
Identify legal and policy issues resulting from “dual use” research
Clinical Research and the Law: Compliance Issues for Research Sponsors
Students will learn to:
Identify the laws, regulations, and standards to which clinical research sponsors
are expected to comply, both in the United States and globally
Evaluate factual scenarios to identify compliance risks and develop strategies for
responding to them
Assess the strengths and weaknesses of proposals to expand, reduce, or modify research
sponsors’ compliance obligations
Clinical Research and the Law: Ethical and Regulatory Issues in Designing Clinical
Trials
Students will learn to:
Navigate the maze of regulatory requirements applicable to clinical research with
human participants
Evaluate proposed research projects to determine whether they meet the criteria for
institutional review board (IRB) approval
Analyze proposed regulatory changes and assess their potential impact on researchers,
research subjects, institutions, and sponsors
Compliance Issues in the Life Sciences - Advertising, Promotion and Transparency
Students will learn to:
Identify key sources of law applicable to drug and device advertising and promotion
and explain what companies must do to comply with these requirements
Distinguish between off-label promotion and scientific and educational exchanges
Recognize the impact of transparency and disclosure requirements on companies’ relationships
with healthcare providers
Develop strategies for avoiding government enforcement action by designing policies
and practices that reflect legal requirements
Assess the industry’s approach to self-regulation and discuss the opportunities and
risks of using social media platforms for advertising, promotion, and patient relations
Compliance Issues in the Life Sciences - Fraud and Corruption
Students will learn to:
Identify the primary legal, regulatory, and ethical standards with which pharmaceutical
and medical device companies must comply
Articulate best practices in corporate compliance in the life sciences industry
Assess the risks of various business strategies and transactions from a fraud and
abuse perspective
Cybersecurity and Privacy I: Law & Policy
Students will learn to:
Identify key sources of law applicable to the Internet as a decentered, community-standards
focused network system
Assess risks to cybersecurity from mismanagement, crime, terrorism, and war
Evaluate proposed changes in the law related to cybersecurity and assess their implications
for the industry and civil society
Cybersecurity and Privacy II: Compliance & Risk Management
Prerequisite: INDL7550 Cybersecurity I
Students will learn to:
Apply industry-leading data security and privacy compliance frameworks to realistic
examples
Conduct qualitative and quantitative cyber risk assessments and transfer cyber risks
Prepare for and comply with legal requirements relating to data breaches and other
legal process for digital information
EU Data Protection and Privacy Law: The GDPR
Students will learn to:
Apply the European Union's General Data Protection Regulation (GDPR) to different
business practices and technologies
Incorporate key principles of European human rights law into an analysis of data protection
practices and policies
Anticipate future directions in the evolution of European data protection and information
privacy law
FDA Regulation and Liability
Students will learn to:
Recognize the differences between the FDA’s approach to pre-market authorization of
drugs, biologics, and devices
Evaluate how the FDA enforces its regulatory requirements and the implications of
enforcement mechanisms for individuals and companies
Explain when state tort claims against drug and device manufacturers are preempted
by federal law and when they are not
Global Corruption: Regulation, Compliance, and Enforcement
Students will learn to:
Identify red flags in business activities that would require further assessment for
compliance with anti-corruption laws
Analyze company activities to determine whether they violate the U.S Foreign Corrupt
Practices Act, the UK Bribery Act, or other laws
Articulate the key elements of a global anti-corruption compliance program
HIPAA Privacy and Security
Students will learn to:
Evaluate and determine whether a given authorization, privacy policy or business associate
agreement complies with HIPAA
Identify and articulate the potential enforcement methods and outcomes and the requirements
for breach notification
Assess and critique the regulatory choices made under HIPAA
Elective Courses
Must take two. Can be from any of the concentration areas (including life sciences law courses above).
Casinos & Hospitality Law
Children's Health and the Law
Collegiate Athletics Law & Policy
Compliance Issues for Healthcare Providers
Conducting Internal Investigations
Consumer Data Privacy Law
Entertainment Law: Legal Regulation of Industry Practices
Entertainment Law: Torts
Financial Crimes Compliance
Financial Privacy Law
Gaming Law I
Governance, Compliance, Enforcement and Risk Management
The Master of Legal Studies (MLS) degree with a concentration in Pharmaceutical and
Medical Device Law & Compliance at Seton Hall Law School is designed for professionals
seeking to deepen their understanding of the legal and regulatory frameworks governing
the life sciences industry.
