TUESDAY, May 18, 2010

Off-Label Promotion: Dos & Don’ts for Monitoring and Maintaining Promotional Compliance

Your company has clear rules and procedures on promotional compliance, and none of your staff violates them, right?

According to a December 24, 2009 Untitled Letter, one large pharma company rep did just that, telling a DDMAC representative that their drug could be used by itself, even though it was not FDA approved this way and still required additional studies.

Perhaps now is a good time to ensure everyone on your team knows what is, and is not, acceptable to say and write about your products. In this 90-minute webinar, regulatory partner Alan Minsk will review the rules pertaining to off-label communication. He will show where FDA’s enforcement efforts are focused, and explain where the line between off-label promotion and scientific exchange exists.

After this program, you will know:

Five (5) key takeaways, based on recent FDA enforcement actions
Typical promotion defects—the red flags to remove from your marketing ASAP
“Is this scientific exchange, or off-label promotion?” 3 factors to consider.
Medical Affairs and MSLs are not allowed to promote off-label. So what can they do, and what role can they play in scientific exchange?
Where the FDA looks for promotion non-compliance
What the Good Reprint Practices guidance does, and does not, say on sharing of off-label use information.

He will also answer your team’s questions in the Q&A session.

Who should attend...

Sales executives, directors, managers, and detailers
Marketers and copywriters
Compliance and regulatory affairs professionals
General, corporate, outside counsel
Pharma and Medical Device executives

For one low price, you and your entire team from one location can take part in this fast-paced, insightful webinar. Best of all, you'll be able to connect personally with our panelists when we open up the phone lines for live Q & A.

SPEAKERS

Alan Minsk is a Partner and Practice Leader of the Food & Drug Practice Team of Arnall Golden Gregory LLP.

He advises pharmaceutical and medical device companies on all legal and regulatory matters relating to the FDA and DEA. He counsels, speaks and writes on a wide variety of FDA-related issues, including regulatory strategy and lifecycle management, FDA enforcement, market exclusivity, FDA inspections, corporate compliance, promotion and advertising, product liability, imports and exports, and clinical trial issues. He also conducts in-house training on a wide variety of FDA and fraud and abuse-related topics.

Alan serves on several editorial boards, has been published in numerous professional journals, and is a frequent speaker at industry events. He earned his J.D. from Georgetown University.

REGISTRATION

Online: Click here for the CD-recording + transcript = $349
By email: custcare@elsevier.com
By phone: +1(800)332-2181 (U.S.) / +1(908)547-2159 (non-U.S.)

Webinar Cancellation Policy:

No refunds or credits will be given one week prior to the scheduled webinar, or after the webinar presentation materials and access instructions have been sent to participants. In lieu of cancellation, you may substitute another delegate from your company as a replacement.

Webinar Details

DATE: Tuesday, May 18, 2010
TIME: 10:00 a.m. PT / 1:00 p.m. ET

DURATION: 90 Minutes

Benefits

What does registration provide?

One (1) phone line, for you alone, or around which to gather your team(s). Toll-free in the U.S. only.
One (1) password to a website on which you'll be taken through the presenters' slides as they speak to them.
An interactive Q&A round with speakers by phone and electronic submission.
Online access to the audio and slides of the entire event if you can't attend the webinar live, and still want to hear the content.
The insight you've come to expect and respect from Elsevier Webinars and our guest speakers.

What are the benefits of a webinar?

Convenience – and lower cost. Your entire team can listen in one room. No travel required!
A team approach. If you've ever wanted everyone on your team to receive the same knowledge and insight you derive from physical conferences... Now you can.
Interactivity. You're remote, but not removed. Our webinars let you ask the important, burning, controversial questions of our speakers that you'd be able to pose at a physical conference.
Flexibility. Want to be able to review what you learn? No problem ... just register for the live webinar PLUS a digital copy of the entire event to listen to at your convenience. Interested in the topic but have a scheduling conflict? Don't worry — the recording is available for purchase at any time