New Webinar from Pharmaceutical Education Associates: Off-Label Communications: How to Develop Internal Policies and Procedures to Help Maintain Compliance
Thursday, November 29, 2007, 10:30 a.m. ET
The dissemination of scientific information on off-label uses of drugs and medical devices has been and remains an area of interest for government officials including the Department of Justice and United States Attorneys who investigate and prosecute health care fraud.
There are complex and often unclear laws, regulations, and guidelines that address dissemination of off-label information. It is important for companies in the pharmaceutical, biotech and medical device industries to be familiar with these rules and how they have been interpreted by regulators and the courts. Such an understanding is a critical underpinning that enables companies to develop internal policies and procedures that maintain compliance while effectively promoting regulated products. In addition to establishing your own compliance program, your company must be able to show regulators that you have established a company culture of clear communication and active participation in the compliance program. This can be accomplished through effective auditing monitoring and training.
This webinar will cover:
* Managing unsolicited requests for off-label information
* Supporting continuing medical education
* Disseminating peer-review studies including off-label information
* Help seeking ads
* Subpart H products
* Lessons learned from government investigations to help you in your proactive compliance efforts
* How to implement compliance controls and training programs specific to off-label dissemination
* How to audit and monitor your key off-label risk areas
* Developing an understanding of how the Government approaches damages analysis for off-label settlements.
* Building controls to potentially mitigate exposure in off-label investigations
Don’t miss your opportunity to hear industry experts discuss these very important strategies to help your company stay in compliance of dissemination of scientific information!
Presenters:
Gregory H. Levine, Partner, FDA Healthcare Practice
ARNOLD & PORTER LLP
Paul Silver, Managing Director, Life Sciences Leader
HURON CONSULTING GROUP
Who Should Attend:
Executives and senior level directors from the pharmaceutical, biotech or medical device industries especially those with responsibilities in the following areas: Chief Compliance, Ethics and Privacy Officers ? Presidents and Vice-Presidents of Sales and Marketing ? Vice-Presidents of Medical Affairs and Marketing Communications ? Product Managers ? Vice-Presidents of Business Development ? Health Law Attorney
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 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’s guidelines regarding off-label communications
Course Level: Intermediate
Learning Objectives:
* Learn how to address unsolicited requests for off-label information
* Receive guidance on developing internal policies and procedures to maintain compliance while promoting regulated products.
Continuing Legal Education:
Upon conclusion, this program will be submitted for review and approval to the NY State Board of CLE. Approval decision timeframe from NY State CLE Board is approx 24-36 weeks. Certificates will be sent out via email upon receipt of approval. A certificate of attendance will be issued individually that you can use to apply for CLE credit in another state.
Individual price: $395
Site License: $1995
Webinar Code: WP171
For more information or to register, please visit the Pharmaceutical Education Associates website.
