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 of Study
The MLS candidate must complete 31 credit-hours of coursework online or at the Law
School. The MLS candidate’s curriculum for the Master of Legal Studies with a concentration
in Pharmaceutical & Medical Device Law & Compliance track is made up of four required
foundation courses, four core courses and two elective courses. The program begins
three times a year: in January, June or September with the 4-credit Introduction to
Law and Legal Writing to orient the MLS student to the tools of legal reasoning.
Required Courses
Must take all in sequence
All courses are offered ONLINE only
Required Courses
HLTH 7390 - Intro to Law and Legal Writing
4 credit(s)
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HLTH 7409 - Torts-Liability for Civil Wrgs
3 credit(s)
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HLTH 7400 - Fundamentals of Business Law
3 credit(s)
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HLTH 7402 - Constitutional Law Survey
3 credit(s)
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Core Courses *
Select four:
12 credits
HLTH 9529 - Biotechnology and the Law
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HLTH 7685 - CRL: Compl Iss for Res Sponsr
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HLTH 7680 - CRL:Ethical Reg Iss Des Cl Trl
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HLTH 7590 - CILS-Advertising-Promo-Tran
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HLTH 7580 - CILS-Fraud and Corruption
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INDL 7550 - Cybersecurity & Prv I:Lw & Pol
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INDL 7555 - Cyber & Prv II: Comp Rsk Mgmt
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CORP 7180 - EU Data Pro and Pv Lw:The GDPR
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HLTH 7560 - FDA Regulation and Liability
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CORP 7160 - Global Corrup-Reg-Com and Enf
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HLTH 7504 - HIPAA Privacy and Security
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Elective Courses **
Select two:
6 credits
INDL 7326 - Casinos & Hospitality Law
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HLTH 7524 - Children's Health and the Law
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INDL 7328 - Collegiate Athletics Lw & Pol
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HLTH 7670 - Comp Iss for Hlth Care Prov
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LABR 7030 - Cond Internal Investigations
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INDL 7306 - Consumer Data Privacy Law
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INDL 7316 - Entertainment Lw:Reg of Ind Pr
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INDL 7313 - Entertainment Law: Torts
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CORP 8160 - Financial Crimes Compliance
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CORP 7185 - Financial Privacy Law
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INDL 7400 - Gaming Law I
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INDL 7401 - Gaming Law II
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CORP 7144 - Govern-Compl-Enforce-Risk Mgmt
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HLTH 7519 - Introduction to Bioethics
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CORP 7140 - Introduction to Corporate Law
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LABR 7000 - Manag Leg Iss in the Workplace
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INDL 7333 - Prof Sports Law and Policy
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PUBR 7905 - Race and Found of American Law
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INDL 7336 - Sports Bet & Fantasy Sports
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HLTH 7690 - Stark Law and Compliance
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HLTH 7660 - The Law of Patient Care
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INDL 7332 - Title IX Gender Equity Sports
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LABR 7600 - Workplace Privacy Law
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Total Hours
31
*
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.
**
Must take two
Can be from any of the concentration areas (including life sciences law courses above)
