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MLS - Pharmaceutical & Medical Device Law & Compliance

MLS - Pharmaceutical & Medical Device Law & Compliance

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Master of Legal Studies (MLS) degree with a concentration in Pharmaceutical and Medical Device Law & Compliance.

This program 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 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.

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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).

View Complete Course Information in the University Catalogue →
The Seton Hall University Catalogue is the definitive source for up-to-date course offerings and degree requirements.

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