• How to make an FDA trial "work" for CMS.
• How FDA's and CMS's data demands compare.
• What to do before you start a trial-to make it do "double-duty."
• What to do after a trial-if you want to make it do "double-duty."
• You will get practical advice, do's and don'ts, and real-world insight from people who have been there and done that.

Compliance-Alliance Audio Conference
"Doing Double Duty": Collecting Data for FDA and CMS in the Same Study

What You Will Learn:

• What kind of clinical data do FDA and CMS want?
• How do the data endpoints preferred by each agency differ?
• What is best approach in choosing comparators?
• Does quality of life data matter?
• What data are crucial vs. "nice to know"?
• Is modeling a reasonable option?
• What about post-market data collection?
• Am I asking for trouble by trying to make one study do double-duty?

Faculty:
Paul Rudolf, MD, JD, formerly a senior advisor for medical and health policy in the Office of the Commissioner, FDA and, a medical advisor in the payment policy division, Medicare, CMS; now a partner with Washington law firm of Arent Fox
Barbara Calvert, Director of Medical Products Reimbursement at Abbott Laboratories
Gregory de Lissovoy, PhD, Vice President and Senior Research Scientist, the MEDTAP Institute, United BioSource Company, Bethesda, Maryland
Ron Geigle, of Polidais, a Washington policy analysis and public affairs firm
Stephanie Mensh, Reimbursement expert
Nancy Singer, President, Compliance-Alliance.

What is an Audio Conference Recording?
An audio conference is an interactive lecture delivered over the telephone. We offer an audio recording of the conference accompanied by a Power Point Presentation to which the speaker referred.

Cost:
The audio CD plus the conference materials is available for $95.

For questions about the audio CD, contact
Nan Matthews at nan@themattgrp.com or 1-303-843-6414