5th Annual Off-Label Usage Conference
A practical guide to managing risks and meeting business objectives
September 20 – 21, 2006 * Philadelphia, PA
For more information or to register, please visit the conference website.Attend this conference and learn how to benefit from off-label profit without putting your business at risk
In todays world of off-label drug and device usage, companies walk a fine line between following the governmental regulatory guidelines and meeting business objectives. Interpreting the rules is often a confusing and daunting task, especially when it comes to issues such as pediatric dosages of medicines and prescribed drugs for oncology patients.
Pharmaceutical Education Associates has gathered together individuals from major pharmaceutical companies, regulatory bodies such as the FDA and the DOJ, healthcare education organizations, healthcare litigation experts, and even experts from overseas on European guidelines for off-label usage for this conference. They will clarify every aspect and detail of off-label usage. You will walk away with a thorough understanding of how to follow the guidelines and maximize the legal avenues of expression concerning off-label usage communication.
Dont miss the pre-conference workshop where the experts will clearly define how to develop, implement and maintain an effective off-label usage program for your organization. The session will be interactive, starting with a panel discussion, followed by small group work, and ending with a question and answer period.
Pharmaceutical and medical device executives should know more than just the current practices of their competitors; you also need to know how to improve upon these practices. This conference clarifies the risks that impede healthy practice, knowledgeable planning, and profits from off-label usage.
Hear From Our Distinguished Speaker Faculty
Steven J. Brotman, MD, JD.
Senior Regulatory Attorney
BRISTOL MYERS SQUIBB
Gary Magistrelli Ph.D.
Sr. Manager, Regulatory Affairs, Medical Review, Advertising & Promotion
TAP PHARMACEUTICAL PRODUCTS INC.
Vice President and General Counsel
BAYER PHARMACEUTICAL CORPORATION
Regulatory Counsel, Office of Compliance
FDA, CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
Brian P. Russell Rph, MBA
President and Chief Compliance Officer
INSTITUTE FOR CONTINUING HEALTH CARE EDUCATION
Mark H. Schaffer
Vice President of CME Compliance
Principal Advisor of Regulatory Affairs
REGULATORY AND CLINICAL RESEARCH INSTITUTE
Assistant Attorney General
STATE ATTORNEY GENERALS OFFICE
Francis P. Crawley
Secretary General and Ethics Officer
EUROPEAN FORUM FOR GOOD CLINICAL PRACTICE
Alan Minsk Esq.
Partner and Chair, Food and Drug Practice Team
ARNALL GOLDEN GREGORY LLP
BERG AND ANDROPHY
T. Reed Stephens
SONNENSCHEIN NASH & ROSENTHAL LLP
Assistant U.S. Attorney
EASTERN DISTRICT OF PENNSYLVANIA
Assistant U.S. Attorney Chief of Healthcare Fraud
U.S. DEPARTMENT OF JUSTICE
COALITION FOR HEALTHCARE COMMUNICATION
of Counsel, WILEY REIN & FIELDING LLC
James M. Wood
REED SMITH LLP
Allison J. Dennis
REED SMITH LLP
SKADDEN, ARPS, STATE, MEAGHER & FLOM LLP
Senior Director Risk Management
For more information or to register, please visit the conference website.