June 16-19, 2008 - Monday - Thursday, 8:45-5:00 p.m.

Health Care Compliance Certification Program

The Health Care Compliance Certification Program is a multi-day educational "bootcamp" for compliance professionals and lawyers who work in the pharmaceutical and medical device industries.  The Health Care Compliance Certification takes place at Seton Hall Law School in Newark, N.J. 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.

June 20, 2008 - Friday, 8:30-3:00 p.m.

Off-Label Promotion of FDA Approved Drugs and Devices: The Good, the Bad & the Ugly

Session Topics: 

▪  Keynote Speaker Paul Kalb, M.D., Partner, Sidley & Austin, will present "Off-Label Investigations and Their Public Health Implications"
▪  Update on the FDA’s Industry Guidance on Good Reprint Practices
▪  The pros and cons benefits of off-label promotion
▪  First amendment issues, new case law & pending litigation
▪  Best practices for medical education and product  promotion

Program Agenda

HCCCP Attendees: This educational program is open to all
current and past attendees of the Seton Hall Law’s Health Care Compliance Certification Program; however, HCCCP attendance is not a prerequisite of this program.

To register click here.

If you have questions, please contact Simone Handler-Hutchinson, Director, Health Care Compliance Certification Program, 973-642-8863 or handlesi@shu.edu

Registration Fee: $125 (Free to SHU Faculty & Students)
Includes continental breakfast, lunch and parking
4 NY CLE credits

"Off-Label Promotion of FDA Approved Drugs & Devices: The Good, the Bad & the Ugly" has been underwritten by a generous grant from Ortho-McNeil Janssen Scientific Affairs, LLC.

Driving directions to Seton Hall Law School are below.  For mass transit directions, click here.  We will validate parking for the Kinney/Central Parking garage attached to the Law School (entrance on Mulberry Street).  Please bring your parking ticket with you.

October 23-24, 2008

Preparing for a Pharmaceutical Response to Pandemic Influenza

For further information, click here.
 

The Law School is located at
One Newark Center, Newark, NJ 07102

Use the following address when using mapping programs or GPS:
1109 Raymond Boulevard, Newark NJ 07102

From the NJ Turnpike, take Exit 15W: Follow I-280 West to Exit 15. Take Route 21 South (McCarter Highway) 1/4 mile. *You will pass Center Street (where NJPAC is located) and Don Pepe’s Restaurant. The next intersection is Raymond Boulevard. Turn right onto Raymond Boulevard. Make the next right onto Mulberry Street. At the traffic light (Park Place), make a right directly onto the entrance ramp of the Central Parking garage which is adjacent to Seton Hall Law School. At Level C, near the elevators, exit onto the front patio of Seton Hall Law School. The entrance to the Law School is on Raymond Boulevard directly ahead of you and to your left. 

From the Garden State Parkway South, take Exit 145: Follow I-280 East to Exit 15. Take Route 21 South (McCarter Highway). Follow directions as above*. 

From 280 East, take Exit 15. Take Route 21 South (McCarter Highway) 1/4 mile. Follow directions as above *.

From Route 22 East, take Route 21 North/McCarter Highway. Turn left onto Raymond Boulevard. (The Hilton will be on your right.) Make the next right onto Mulberry Street. At the traffic light (Park Place), make a right directly onto the entrance ramp of the Central Parking garage which is adjacent to Seton Hall Law School. At Level C, near the elevators, exit onto the front patio of Seton Hall Law School. The entrance to the Law School is on Raymond Boulevard directly ahead of you and to your left.