Advertising and Promotion of Medical Devices in an Age of DTC and Social Media Marketing

Thursday, November 05 – Friday, November 06, 2009

Washington, DC Metro Area | Offices of Morgan Lewis


SPECIAL PROMOTION - Please do not submit your registration online, we will do it for you!

AdvaMed's MTLI is offering a $250 discount on all remaining 2009 courses. In order to obtain the $250 discount, please visit our website at www.advamedmtli.org and complete the registration form but do no submit it online.

After completing your registration form, PDF the form and email it to kkunze@advamed.org or print it out and fax it to 202.783.8750 Attention: Katia. Please indicate your request for the $250 discount in the body of the email or the fax cover sheet and we'll take it from there. Some restrictions may apply.

 

What are the regulatory and legal guidelines for appropriate advertising and promotion of medical technologies? How and when are companies permitted to disseminate off-label information or to respond to physician requests? What internal systems and controls should companies have to comply with regulatory guidelines and the AdvaMed Code of Ethics? Where is DTC advertising going? What are the recent trends in FDA enforcement and OIG prosecution of infractions? Legal experts, company compliance officers, and representatives from FDA offer guidance in these and other areas.

 

Click here for the Full Agenda


Who Should Attend

Those persons involved with Communications/Public Affairs, Sales and Marketing, Product Managers, General and Regulatory Counsel, Regulatory Affairs and Compliance Officers.


Registration
AdvaMed Member $1295 Register Now
Non-Member $1915
AdvaMed EGCC Member $1095
Government $495

Agenda Overview
View Full Agenda
Overview of the Regulation of Medical Device Advertising and Promotion
CDRH Office of Compliance and Medical Device Advertising
The Ferderal Trade Commission and the Regulation of Medical Devices
Presenting Risk Information in Promotional Materials
Good Reprint Practices and the Dissemination of Clinical Information
Data Disclosure and Allowable Claims
Practical Considerations in Developing Promotional Materials
The View from the Drug Side
How Current DOJ, OIG, and Whistleblower Suits Affect Promotional Activities - an Update and Forecast
AdvaMed's Guiding Principles for DTC Advertising
DTC Advertising Case Study
Regulatory and Legal Considerations on the Use of New Social Media - Twittering on Legal Trends
New Social Media, Marketing, and Health Information Dissemination

Click here for the Full Agenda


Speakers

Marlene Tandy, MD, JD, Senior Counsel, Johnson & Johnson
Deborah Wolf, Acting Director, Promotion & Advertising Staff, Office of Compliance, FDA/CDRH
Andrew Strenio, Partner, Sidley Austin, former Commissioner, Federal Trade Commission
Mark Heller, Partner and Chair of FDA Group, Goodwin & Proctor
Tony Blank, Vice President, Cardiovascular Regulatory Affairs, Boston Scientific
Marissa Chaet Brykman, Regulatory Counsel, Division of Drug Marketing, Advertising, and Communications, FDA/CDER
Kathleen McDermott, Partner, Morgan Lewis
John Rah, Partner, Morgan Lewis
Sandy Kalter, Senior Legal Director and FDA Counsel, Medtronic
Kathleen Sanzo, Partner, Morgan Lewis
Robin Strongin, President, Amplify Public Affairs
Joel Selzer, Co-Founder & CEO, Ozmosis, Inc.
Julie Loughran, Vice President, iConecto
Lars Merk, Product Director, McNeil Pediatrics, Ortho-McNeil Janssen Pharmaceuticals, Inc.
Rebecca Wood, Partner, Sidley Austin

Click here for the Full Agenda

- Back to Top -


General Information

It is the responsibility of the registrant to verify their company’s active membership status prior to registering.  You may check if your company is an active member by clicking here.  There will be no adjustments or refunds made for registrations made as non-members, when registrant’s company is a member company.  Higher non-member rate will be charged for registrations received under member registration when companies are found to be non-members.

For Sponsorship Opportunities, Hotel Information and Seminar Logistics, please contact Veronica Allen.  For information regarding Registration issues, please contact Katia Kunze.

Please be advised that any registrations received after 5 pm on Friday October 23rd will not appear on the participants roster.  It is MTLI policy not to release revised participants rosters after the seminar.

CANCELLATION & REFUND POLICY

All cancellations must be received in writing by Katia Kunze. All cancellations received 11 business days or more prior to the start of the program are subject to a 10 percent cancellation fee. There will be NO REFUNDS for cancellations received within the 10 business days prior to the start of the program including "no shows".

We welcome substitutions in lieu of cancellations at any time. Please contact Katia Kunze with the substitute's information. All cancellation refunds will be processed within 30 business days from date cancellation request is received.  Topics and speakers are subject ot change without notice.  Advamed reserves the right to cancel or reschedule any program, whereupon full registration feew will be refunded or applied to the rescheduled program in accordance with the registrant's preference.  In the event of cancelled programs, AdvaMed assumes no responsibility for transportation, hotel, or other expenses incurred by registrants.

- Back to Top -


Location Information

This seminar will take place at the Law Offices of Morgan Lewis, Washington, DC located at:

111 Pensylvania Ave., NW
Washington, DC  20004
202.739.3000

Please be advised that there are no hotel room blocks associated with this seminar. For your convenience we have listed below a list of hotels near the Morgan Lewis offices:

- Back to Top -


Frequently Asked Questions

- Back to Top -