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The Health Care Compliance Certification Program is a
multi-day educational program for compliance professionals
and lawyers in the pharmaceutical and medical device
industries that takes place at Seton Hall Law School in
Newark, N.J. The Program addresses the issues faced by the
pharmaceutical and medical device industries in complying with such
standards as the
OIG’s
Compliance Program Guidance for Pharmaceutical Manufacturers (.pdf),
the PhRMA Code (.pdf), and the
AdvaMed Revised
Code of Ethics (.pdf). The program immerses attendees in
the statutes, regulations, and other guidance that comprise
the body of law known as “fraud, waste, and abuse law,” as well as
FDA law, so they can understand the legal underpinnings of
the compliance programs that they enforce.
Throughout these days of intensive and interactive study,
attendees learn (among other things):
- The federal laws and regulations that provide the foundation of the government’s oversight
of fraud and abuse generally, and more specifically the foundation of the
OIG’s Compliance
Program Guidance for Pharmaceutical Manufacturers (.pdf);
- The public policy objectives of the federal government’s oversight of fraud and abuse in the
health care industry;
- The FDA’s regulatory scheme and its intersection with fraud and abuse laws;
- The federal laws and regulations that are implicated in the course of administering a corporate
compliance program;
- The ethical and legal principles that underlie a strong corporate compliance effort;
- The state laws that address fraud in the pharmaceutical and medical
device industries; and
- How the federal and state government investigate and enforce the fraud and abuse laws.
Participants are required to attend all sessions
throughout the four-day program in order to be eligible for
certification. This attendance policy is in place of an
exam. No exam will be given at the conclusion of the program
(excluding MSJ students who are taking this course for
credit). The schedule is available at
Program Schedule,
and participants are urged to plan their visit with us
accordingly.
Faculty for this program include high-level government and private lawyers who are expert in
pharmaceutical and device fraud and abuse issues. Attendees will receive a certificate at the
end of the week for participating in the Program. Seton
Hall Law School's Health Care Compliance Certification
Program is accredited by HCCA (Health Care Compliance
Association). In addition to receiving a certificate from
the Law School, each participant will receive an HCCA
certificate of credit. Attendees will
receive a flashdrive or a resource
book that will aid them in their ongoing compliance efforts. Students
enrolled in Seton Hall Law School's Master of
Science in Jurisprudence program may receive 1 credit for
participating in this Compliance Certification Program. For
further information, please see
Receiving Credit: Our M.S.J.
Students.
For additional information, contact Simone
Handler-Hutchinson at (973) 642-8863,
handlesi@shu.edu.
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