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Certificate in Pharmaceutical and Medical Device Law and Compliance

 

Division of Online Learning

lawonline@shu.edu | 973-642-8747 or 973-761-9000 ext. 8747

The graduate certificate in Pharmaceutical & Medical Device Law & Compliance is designed for professionals seeking to enhance their knowledge of legal, regulatory and ethical issues in the pharmaceutical and medical device industries. The target audience includes pharmaceutical and medical device professionals in compliance, legal, regulatory and medical affairs, sales, marketing, grants and related areas.

Each course takes eight weeks to complete, and you may take them in any order you choose. Courses offered are:

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: Law, Policy, Compliance

This course examines the legal, policy, and compliance challenges raised by efforts to protect the Internet and other forms of networked computer systems from attack by hackers, organized criminal groups, terrorists, and others. Topics include:

  1. Threats to cybersecurity

  2. Domestic and international Internet governance

  3. The Computer Fraud and Abuse Act

  4. U.S. and European Union privacy law and personal data protection

  5. War, international terrorism, and U.S. surveillance law

  6. Private information infrastructure and the law of emergencies

  7. Emerging compliance frameworks for cybersecurity

3

online

CORP7180

EU Data Protection and Privacy Law

This course introduces students to the legal regime governing information privacy, data protection, and data security in the European Union. Topics covered include the privacy jurisprudence of the European Court of Human Rights, the EU Data Protection Directive and the General Data Protection Regulation, data protection authorities, international data transfers, 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

 

A Certificate in Pharmaceutical & Medical Device Law & Compliance will be awarded upon completion of three courses. You must take three online pharmaceutical law certificate courses listed above, in any order you choose.

Materials for the certificate program are drawn from a broad range of statutory and regulatory texts, agency guidance documents, enforcement actions, settlement agreements, judicial decisions, and expert commentary. Through a series of multimedia presentations, guided discussions and individually supervised writing projects, students learn to interpret legal documents and assess their business implications.

All of our graduate certificate courses offer intensive, individualized feedback, as well as an opportunity to develop the practical skills necessary to research and communicate effectively about the law.

All nine credits earned while completing the online certificate in medical device law can be applied towards the MSJ degree.

New course sessions begin five times per year.

To apply for admission into Seton Hall Law’s certificate program in Pharmaceutical & Medical Device Law and Compliance, please submit the following:

  1. Online application
  2. Confirmation of Baccalaureate degree from a college or university
  3. Current resume or employment information

*No entrance exam is required for admission.


 


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