Health Care Compliance Certification Program*
A Certification Program for Pharmaceutical, Biotech and Medical Device Compliance Officers
The Healthcare Compliance Certification Program (HCCP) 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, and occasionally at off site locations. 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 guidances that comprise the body of law known as “fraud and abuse law,” as well as other healthcare related laws and regulations which will help them understand the legal underpinnings of the compliance programs they develop and enforce.
> Access to the Healthcare Compliance Certification Program Director and Registration Information
What topics are covered?
Throughout the four days of intensive and interactive study, attendees learn (among other things):
1. The federal laws and regulations that provide the foundation of the government’s oversight of fraud and abuse generally
2. The FDA’s regulatory scheme and its intersection with fraud and abuse laws;
3. The federal laws and regulations that are implicated in the course of administering a corporate compliance program and the ethical and legal principles that underlie a strong corporate compliance program;
4. State and federal regulations affecting the sales and marketing practices of drug and device companies;
5. Government pricing programs;
5. Federal healthcare programs for drug and device manufacturers;
7. Privacy and data protection and state, federal and international privacy issues;
8. The Foreign Corrupt Practices Act and the risks to companies conducting business abroad; and
9. 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 strict attendance policy is lieu of an exam. With the exception of MSJ students who are taking this course for credit, there will be no exams given at the conclusion of the Program. The 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 includes 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 written resource material 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 Program. For further information, please see Receiving Credit: Our M.S.J. Students.
Questions?
For additional information, contact Jessica Kwon at (973) 642-8190, jessica.kwon@shu.edu.