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The MSBA's Food and Drug Law Section in collaboration with LifeScience Alley Presents

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"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.

Topics include:

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

Now what?

  • 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

Speakers:

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

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Details:

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 
[Directions/Map]

Registration will begin at 7:30 a.m., followed by the program from 8:00 - 10:00 a.m.

Cost:

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.