Health Care Compliance Certification Program
Upcoming Program: October 26-29, 2009 (On-line Registration)
The Healthcare Compliance Certification Program is a multi-day educational program for compliance professionals and lawyers in the pharmaceutical, biotech and medical device industries. 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. 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.
What topics are covered?
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.
What are the attendance requirements?
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). A draft schedule is available at Program Schedule, and participants are urged to plan their visit with us accordingly.
Who are on the faculty?
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 Healthcare 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.
Who should attend?
Pharmaceutical and medical device professionals in compliance, legal, regulatory, sales, marketing, grants, and related areas.
Are course materials available?
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 the Healthcare Compliance Certification Program. For further information, please see Receiving Credit: Our M.S.J. Students.
Questions?
For additional information, contact Simone Handler-Hutchinson at (973) 642-8863, handlesi@shu.edu.