A 100 minute course entitled “Legal and Regulatory Update for Publication Planners” will be held 1:00 p.m. ET on Thursday, January 24, 2008.
In today’s environment, companies need to be aware of the current regulatory and compliance “hot buttons” to maintain compliance and manage the risk of criminal prosecutions and civil litigations. This webinar will provide updates on the most pressing and relevant regulatory issues the life sciences industry must know about to help stay on the right side of compliance.
Topics will include:
* Theory vs. practice: a discussion on the most likely areas of violation and review of industry violations
* The implication of involving commercials in the publication planning process
* Off-label dissemination: the implications of FDA requirements and the WLF
* Fraud and Abuse considerations
* The False Claims Act
* Anti-kickback violations
Bring your toughest questions because you will have the opportunity to ask the speakers questions during this interactive, online event.
Distinguished Panel:
Anne K. Walsh, Associate Chief Counsel, U.S. FDA, Food and Drug Division
OFFICE OF GENERAL COUNSEL FOOD AND DRUG ADMINISTRATION
Ioana Petrou, Chief, Criminal Healthcare Fraud Coordinator
U.S. ATTORNEY’S OFFICE, NDCA
Alan G. Minsk, JD, Partner and Leader, Food and Drug Practice Group
ARNALL GOLDEN GREGORY LLP
General Webinar Details:
Who Should Attend: Publication planning professionals from the pharmaceutical, biotech or medical device industries especially those with responsibilities in the following areas:
* Medical writers
* Medical communications staff
* Publications staff
* Product managers
* Medical communication agencies
* Pharmaceutical consultants
* Law firms with practices focused on the pharmaceutical industry
Prerequisites: Currently work in the pharmaceutical, biotech or medical device industries or act in an advisory capacity to these companies
Advanced Preparation: Be familiar with requirements set forth by the Office of the Inspector General of the Department of Health and Human Services and the Department of Justice as well as the Food and Drug Administration
Course Level: Intermediate
Learning Objectives:
* Develop strong understanding of key regulations and enforcement agencies that impact the publication planning process
* Learn how to reduce the risk of regulatory action, prosecution or litigation
Register today to secure your spot at this one-of-a-kind web seminar brought to you by Pharmaceutical Research Associates, The International Publication Planning Association (TIPPA), and Legal Education Associates.
The fee per individual: $395
Site license: $1,995
(Gives access to multiple attendees from the same company)
To register, please go to the PEA website.
