Certificate in Pharmaceutical and Medical Device Law and Compliance

Division of Online Learning

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

HLTH7680

Clinical Research and the Law

This course examines the legal, regulatory, ethical, and compliance issues that arise for individuals and entities involved in all aspects of clinical trials, including sponsors, researchers, research institutions, contract research organizations, and institutional review boards. Topics covered include:

  1. IRB review

  2. Risk-benefit assessment

  3. Informed consent

  4. Confidentiality and HIPAA compliance

  5. Conflicts of interest

  6. Inclusion of women and minorities in clinical research

  7. Pediatric research

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 & 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

HLTH7560

FDA Regulation & 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

HLTH7504

HIPAA Privacy & 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.


 


Online Graduate Programs | Open House - October 22, 2016



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