Frequently Asked Questions

U.S. Compliance Certification Program for Smaller Life Sciences Companies

PROGRAM SCHEDULED for Fall 2015 | San Francisco, California

What topics are covered?

Please see our program schedule.

Which compliance program is right for me?

Each Compliance Program offered by Seton Hall Law was created for and tailored to a different audience and each has an independent advisory board.

  1. East Coast: Our US Healthcare Compliance Program (HCCP) was established in 2004 and is offered twice per year in New Jersey. It is ideal for medium to large life sciences companies. The HCCP's content, discussions and exercises are geared for companies that have a mature and fairly robust corporate compliance program in place that falls under the direction of a chief compliance, ethics or integrity officer.
  2. West Coast: Our new US Life Sciences Compliance Program (LSCP) is currently offered once per year in California. The LSCP's content, discussions and exercises are tailored toward smaller, newer, and maturing life sciences companies (including start-ups) that may have few or no full-time compliance or legal officers, or have limited resources currently devoted to corporate compliance. Some of these companies may have few, if any, FDA-approved products on the market, and are in the process of growing their national and international footprint.
  3. Both Programs:
    1. Provide a strong legal and ethical foundation for compliance and legal professionals;
    2. Offer opportunities to meet with and learn from other life sciences professionals;
    3. Offer practical insights into how to identify and address life sciences compliance risks and build effective compliance programs; and
    4. Provide a certificate to each attendee upon completion of the program.

Who should attend?

Pharmaceutical and medical device professionals in compliance, legal, regulatory and medical affairs, sales, marketing, grants and related areas, as well as, outside counsel who represent healthcare companies.  The Program is recommended for those who would benefit from an introduction (or an update) to the complex set of laws, regulations and issues affecting the drug and device industries and the government's approach to monitoring and prosecuting violators. It is not recommended for chief or senior compliance officers who are experts in compliance matters.

Who are the faculty?

Program faculty include high-level government lawyers from Federal and state enforcement agencies, private lawyers from leading firms and in-house compliance officers and legal counsel with expertise in compliance matters. A Seton Hall Law professor from the Center for Health & Pharmaceutical Law & Policy participates in each Program.

Does this Program fulfill other accredidation requirements, e.g. CLE and HCCA?

Yes.  In addition to the Program certificate, attendees may apply for:  

  1. CCB: Continuing Education units (CEUs) in Compliance Training and Education and Auditing and Monitoring for Compliance from the Compliance Certification Board (CCB) to be used towards meeting the continuing education requirement to sit for, or renew, a CCB certification. These CEUs can be used towards the Certified in Healthcare Compliance (CHC)®, Certified in Healthcare Compliance-Fellow (CHC-F), Certified in Healthcare Privacy Compliance (CHPC)®, Certified in Healthcare Research Compliance (CHRC)®, Certified Compliance & Ethics Professional (CCEP)®, Certified Compliance & Ethics Professional-Fellow (CCEP-F), Certified Compliance & Ethics Professional-International (CCEP-I).  
  2. NY and NJ CLE: Approximately 20 CLE credit hours.  Seton Hall Law School is an accredited provider for New York and New Jersey CLE credit.  (Note: Attorneys wishing to receive CLE credits outside of New York/New Jersey may need to fulfill additional requirements to receive credit hours and should check with their respective state Supreme Courts/CLE Boards.) CLE Financial assistance is available for qualified registrants - Apply here.

Are course materials available?

Yes.  Attendees will receive electronic resource material that will aid them in their ongoing compliance duties and profession. 

Are discounts available?

Yes.  A discount is available for employers sending 3 or more employees to the program. Members of life sciences trade organizations may also be eligible for a discount. For more information, please contact us at healthlaw@shu.edu or 973-642-8871.

Are scholarships available?

Yes. Please visit our Scholarships page for more information.



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