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Audioconference Agenda

National Audioconference on Advanced Issues in Human Subjects Research Compliance

  • January 30, 2003 - Thursday
8:00 am - 9:30 am H/AST (Hawaii-Aleutian)
9:00 am - 10:30 am AST (Alaska)
10:00 am - 11:30 am PST
11:00 am - 12:30 pm MST
12:00 pm - 1:30 pm CST
1:00 pm to 2:30 pm EST


The Audioconference agenda is set forth in Eastern Daylight Time below:
1:00 pm Audioconference Check in and Introduction

1:05 pm Overview of Audioconference by the Moderator
Michele Russell-Einhorn, Esq.

1:10 pm An Overview of Human Subjects Research --
     (a) What constitutes human subject research?
     (b) How is human subject research regulated in the US?

Michele Russell-Einhorn, Esq.
Presentation Materials in Powerpoint or Acrobat

1:25 pm Review of Key Structural Issue Federal Regulations for the Protection of Human Subjects
     (a) The Federal Policy ("Common Rule") vs. HHS regulations vs. FDA regulations
      for the protection of human subjects
     (b) Differing Approaches to Compliance Oversight: HHS vs. FDA

Tom Puglisi, Ph.D.

1:40 pm The HHS Approach to Compliance Oversight
      (a) Compliance Oversight Mechanisms
      (b) Recent Determinations

Michael Carome, MD
Presentation Materials in Powerpoint or Acrobat

1:55 pm The FDA Approach to Compliance Oversight
      (a) Compliance Oversight Mechanisms
      (b) Recent Determinations

Marian Linde-Serge, RN
Presentation Materials in Microsoft Word or Acrobat

2:05 pm Questions from the Audience

2:30 pm Audioconference Adjournment


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