The MSBA's Food and Drug Law Section in collaboration with LifeScience Alley Presents
"Compliance: Don't Be Too Late Getting Your House in Order"
The MSBA Food & Drug Law Section is proud to co-host this meeting with LifeScience Alley.
Join your colleagues at this insightful session where we will discuss recent changes in FDA's, DOJ's and OIG's enforcement initiatives and on-going prosecutions. We will cover the enforcement landscape. Experienced in-house lawyers and regulatory affairs professionals will also share how they tackle compliance issues with their executive, regulatory, marketing and compliance teams.
Where is government headed today:
- New interpretation of the Responsible Corporate Officer (''RCO'') doctrine
- Recent settlements and plea agreements
- OIG's new ''Roadmap for Physicians on Interacting with Medical Products Companies''
- Sunshine provisions
- State laws
- What are the basic elements of an ideal corporate compliance program?
- OIG, AdvaMed and PhRMA guidance
- What should be in your code and SOPs
- From a general counsel's perspective
- How do you approach compliance?
- What's your focus (general corporate v. FDA advertising and promotion/Anti-Kickback/False Claims)?
- How do you prioritize?
- Analyzing the enforcement landscape for your business
- The value and importance of auditing
Julie Coletti, Chief Legal Officer and Corporate Secretary, Medrad Interventional/Possis
Mark DuVal, President, DuVal & Associates, P.A.
Joy Frestedt, PhD, RAC, CCTI, President and CEO, Frestedt Inc.
Ralph F. Hall, JD, Counsel, Baker & Daniels LLP
Karen Roche, Vice President of Operations and Technology, Spineology
2 hours of Standard CLE credits applied for
Event Code: 151681
Date: Thursday, January 13, 2011
Time: 7:30 a.m. to 10:00 a.m.
Location: Hamline University - Minneapolis
1600 Utica Avenue South
St. Louis Park, MN 55416
Registration will begin at 7:30 a.m., followed by the program from 8:00 - 10:00 a.m.
Section Members: $75.00
Section members should register by using the link above or by contacting LifeScience Alley. Section members are eligible for the $75.00 registration rate.