Preliminary Agenda
Monday, September 21go to Tuesday's agenda >>
7:30 a.m.
Registration and Continental Breakfast
8:30 a.m.
FDLI Welcome and Announcements
I. Conference Chairman’s Introduction and Overview
II. Janet Woodcock, MD, Director, CDER, FDA
III. Enforcement and Policy Updates from FDA’s CBER,
CDER, CDRH and CVM
Refreshment Break
IV. An FDA Update on Direct-to-Consumer Advertising/Draft Guidance on Presenting Risk Information in Prescription and Medical Device Promotion
12 Noon - 1:30 p.m.
Lunch
1:30 p.m.
V. Hot Topics
A. Risk Evaluation and Management Strategy (REMS)
B. Continuing Medical Education, Institute of Medicine’s Conflict of Interest Report, MedPAC Report
C. First Amendment, Press Releases
Refreshment Break
VI. The Use of Social Marketing and Electronic Media
VII. Industry Codes
5:30 p.m.
Adjournment for the Day
5:30 - 6:30 p.m.
Networking Reception
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Tuesday, September 22
go back to Monday's agenda >>
8:00 a.m.
Continental Breakfast
8:30 - 10:30 a.m.
VIII. Concurrent Breakout Sessions
Drugs/Biologics
Medical Devices
Veterinary Medicine
Refreshment Break
10:45 a.m.
IX. The New Transparency
1.
Disclosures on the Internet (i.e. grants)
2.
Ghost Writing
3.
Clinicaltrials.gov
X. International Aspects
12:30 - 2:00 p.m.Lunch with Speaker
Michael K. Loucks, Acting U.S. Attorney, District of Massachusetts, U.S. Attorney’s Office, U.S. Department of Justice
2:00 p.m.
XI. Settlements Update from the Office of the Inspector General, Department of Health and Human Services and the Department of Justice
Refreshment Break
XII. Questions and Answers with FDA Speakers
4:45 p.m.
Closing Remarks and Adjournment
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