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Negotiating Clinical Trial Contracts in a Minefield: The Stark Rule, Anti-kickback Statute (AKS), False Claims Act (FCA) and Medicare Secondary Payer Rule (MSPR)
Thursday, January 10, 2013 from 10:00 AM to 11:30 AM (PST)
This webinar will provide a basic understanding of regulations and statutes that people involved in the clinical research contract negotiation process must be aware of. You will learn how to negotiate for and create federally complaint agreements and thus avoid the risk associated with violations.
Why Should You Attend:
Payment for work done in the execution of a clinical trial would seem to be a straightforward proposition, but in the U.S. a multitude of regulations and statutes and their associated risk can turn contract and budget negotiation into a minefield. Such regulations include the Stark Law, the Anti-kickback Statute, the False Claims Act and Medicare Secondary Payer Rule. All parties involved in the clinical research contract negotiation process must be well versed in these rules in order to create federally complaint agreements and thus avoid the risk associated with violations.
Violations of these rules in the course of clinical research have resulted in heavy fines and penalties for well known and respected institutions.
At the end of this session, attendees will be able to:
- Recount the implications of Stark Law, the AKS, FCA and MSPR on clinical trial contracts and payments.
- Identify contract and budget hot spots and how to manage them.
- Create processes that assure institutional compliance.
- Demonstrate these skills with a live case exercise.
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
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- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.