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Audioconference Agenda

National Pharma Audioconference: Off Label Promotion - Compliance Issues and Practices

  • Thursday, October 2, 2003
1:00 pm - 2:45 pm (Eastern)
12:00 pm - 1:45 pm (Central)
11:00 am - 12:45 pm (Mountain)
10:00 am - 11:45 am (Pacific)





The Audioconference agenda is set forth in Eastern Daylight Time below:

1:00 pm Welcoming Remarks and Introduction of Faculty
Anthony L. Farino

1:05 pm

Government Perspective on Off Label Promotion
Virginia Gibson
Presentation Materials in Powerpoint or Acrobat

1:20 pm

Legal Issues Around Off Label Promotion, including Overlapping Issues between FDA and the False Claims Act
Paul Kalb
Presentation Materials in Powerpoint or Acrobat

1:35 pm

Off Label Promotion: Managing Regulatory Issues - Insights from an In house Lawyer
Michael Misocky
Presentation Materials in Powerpoint or Acrobat

1:50 pm

Off Label Promotion: Assessing and Managing Risk in the Context of an Effective Compliance Program
Lori Queisser

2:05 pm

Questions and Answers

2:45 pm

Audioconference Adjournment


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