Featured Conference
Navigating the Risks of Off-label Usage
To Avert the Legal, Regulatory, Marketing and Medical Implications
February 26-27, 2004 Washington, DC
The postmarket development of pharmaceuticals is vital to the success of many brands; however manufacturers must wrestle with an assortment of issues that ensue. Success, which is often hinged on off-label usage, may sway profits, but also raises many legal, regulatory, financial and health hazards. Risk preventative measures can be implemented to avoid the hazards that are particular to off-label usage. The Navigating the Risks of Off-Label Usage conference addresses how to recognize and avoid behavior that can land your company in legal and financial hot water.
Following up on our highly acclaimed Fall event, Pharmaceutical Education Associates is proud to present the Navigating the Risks of Off-Label Usage Spring 2004 conference, taking place February 26-27, 2004 in Washington, DC.
This exclusive event addresses critical issues including:
- FDA Policies Regarding Off-Label Activity
- Recent Enforcement of FDA Off-Label Regulations
- Identifying False Claims and Safe Harbors
- Essential Postmarket Risk Preventing Measures
- Court Ruling on First Amendment Rights
- Legal Implications Beyond the FDA Regulations
- Assessment of Health Outcomes for Off-Label Usage
- …and much more!
Don’t Miss the Pre-Conference Workshop
Managing Interactions between Pharmaceutical Manufacturers
and Healthcare Professionals Facilitated by Alan G. Minsk, Partner, ARNALL, GOLDEN GREGORY, LLP
Industry Experts Participating Include:
Barbara R. Binis
Partner
REED SMITH, LLP
Thomas M. Conroy
Senior Regulatory Affairs
ABBOTT LABORATORIES INC
Jianefi Guo
Co-Principal Investigator
OHIO MEDICAID DRUG UTILIZATION REVIEW
John Kamp
Of Counsel
WILEY REIN & FIELDING, LLP
Daniel A. Kracov
Partner
PATTON BOGGS, LLP
Arthur Levine
Partner
ARNOLD & PORTER
Geoffrey Levitt
Vice President & Chief Regulatory Counsel
WYETH PHARMACEUTICALS
William McGrath
Partner
WILEY REIN & FIELDING, LLP
Alan G. Minsk
Partner & Leader, Food and Drug Law
ARNALL GOLDEN GREGORY, LLP
Praise for the previous Navigating the Risks of Off-Label Usage conference:
“One of the best meetings I have attended! Structure, content, speaker quality, staff.” MD, Clinical Development, Diagnostics, BERLEX LABORATORIES “I found the conference topics to be very informative and enlightening about where FDA and Industry stand on off-label.” Regulatory Affairs Associate, NABI BIOPHARMACEUTICALS “The program was well thought out and was organized in a logical progression.” Associate Director, Medical Information, FUJISAWA HEALTHCARE
For more information about registering for this conference, visit the conference site.
