From the Publishers of BioWorld Today and Medical Device Daily
When: Wednesday, October 28, 2009
What Time: 1pm to 2:30pm ET
Where: Your office or conference room
Cost: Just $325 per listening site no matter how many people are in the room!
Best Value! Audio Conference PLUS Audio CD and Transcript: $479 ——
Order Now!
Speaker(s): William Kitchens
Duration: 90 Minutes
The promotion of prescription drugs and devices at trade shows and medical meetings is a critical component of marketing success, but questions of regulatory gray areas arise frequently. Well intentioned or not, a misstep in developing your promotions in these forums can lead to major compliance and legal problems. And with the FDA now on enforcement footing, you need now, more than ever, to be sure your efforts are legal.
In this 90 minute audio conference, attorney William Kitchens will explain what legitimate promotional activity in these forums is, and provide guidance on structuring your promotions to avoid regulatory headaches.
Learning Points or Questions to be Answered:
- What promotional activities constitute "labeling"
- Scientific exchange of information vs. promotion
- Red flags that will attract regulatory scrutiny
- How to structure your promotional activities to eliminate the risk of adverse regulatory scrutiny
- Dissemination of appropriate risk information: how to build a case for fair balance
- Specific issues presented when addressing pre-approval and off-label information exchanges
- Steps to ensure lawful and positive interactions with healthcare professionals
Target Audience:
- Corporate executives and directors
- Compliance and regulatory affairs staff
- Business development, sales and marketing professionals
- Trade show staff and pharma/dev meeting planners
- Medical affairs and Medical Science Liaisons
- Medical writers
- Risk management professionals
- CME coordinators
- Doctors and experts who speak at CME events or otherwise engage in "detailing" of healthcare professionals
Level: Intermediate
Meet Your Expert!
William Kitchens is a partner with Arnall Golden Gregory LLP. He practices in the areas of food and drug law, environmental law, and trade association law and advises clients on matters relating to litigation, compliance and enforcement, product approvals, advertising and labeling, and regulatory, licensing, and permitting strategies. He has extensive experience representing clients in federal and state courts and before the FDA, the Department of Agriculture, the FTC, and the EPA.
Bill is a frequent speaker at industry events, and has written numerous articles published in legal journals. He is an Adjunct Professor at Emory University School of Law, where he has taught a course in Food and Drug Law since 1979. He earned his J.D. from the University of Georgia School of Law.
Registration Details:
The registration fee for this audio conference is $325 per connection. You may invite as many participants from your facility as you can accommodate around your conference phone. Call 1-800-688-2421 or click here to register. Mention code 10T09586 EM8383 when registering.
Registration includes:
-- Admittance to the 90-minute call for as many people as you can accommodate around your conference telephone
-- Access to the specially created presentation handouts (available 48 hours in advance)
-- Participation in the 15-minute, live Q&A with the speaker following the presentation
-- Certificates of attendance for all audio conference attendees
Can't attend the live event? A conference CD (MP3 format) is also available.
If you prefer to register, or order the CD recording (MP3 format), by phone, then call us at 1-800-688-2421 or 1-404-262-5474. And when you do, please be sure to mention your priority code: T09586 — EM8383.
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