Federal regulation of the advertising and promotion of pharmaceuticals and medical devices reflects an aggressive attitude on the part of the regulators that demands, in turn, that industry be keenly aware of the legal and regulatory duties, as well as key recent trends in enforcement activities by the Federal Government. This course will explore in detail what FDA requires of drug and device firms as well as recent current hot buttons in FDA enforcement activity for the advertising arena.
What’s at stake if your advertising and promotional efforts violate the law? Colossal fines – the latest was $3 Billion; criminal liability, including even prison time; and huge disruption in operations while dealing with federal probes into illegal marketing.
Key goals of the conference will include learning:
The basics of FDA law and regulations governing advertising and
promotion, as well as sister agencies such as the Federal Trade
Commission, which shares jurisdiction with FDA on certain regulated
products (e.g., OTC drugs).
The distinctions between labels, labeling and advertising and how that impacts FDA's powers, and
How to properly position Direct-to-Consumer (DTC) promotions
The Dos and Don'ts of promoting products on the internet, including social media sites such as Facebook and Twitter
The perils of off-label promotion, including criminal and civil
actions that have led to multi-billion dollar settlements by regulated
Whether the First Amendment provides any insulation for truthful statements regarding regulated products;
When disseminating medical educational materials crosses the line into improper promotion; and
Key considerations on how to implement appropriate procedures and
controls in your company to minimize the potential for regulatory action
by the FDA or the FTC relative to promotion and advertising.
Michael A Swit, Esq., FDA Lawyer
Who will Benefit:
Senior executives, directors, managers and those who have responsibility for implementing advertising and promotional activities, as well as those that have key collateral roles in reviewing advertising for drug and device firms, including officials from these areas within regulated companies:
Michael A. Swit focuses on solving the legal challenges confronted
by the pharmaceutical, medical device, and other life sciences
industries in tackling the myriad of legal mandates enforced by the U.S.
Food & Drug Administration. Mr. Swit has extensive experience
counseling life sciences firms on the demands of compliance with FDA's
statutory and regulatory requirements to develop and market safe and
effective drugs, biologics, medical devices, IVDs and other products. He
also has advised regulated firms on a wide range of FDA regulatory
matters, including drug and device approvals and marketing/promotional
claims, dietary supplement health claims and regulatory issues in
corporate acquisitions. His experience includes FDA development
strategies, compliance and enforcement initiatives, recalls and crisis
management, submissions and related traditional FDA regulatory
activities, labeling and advertising, and clinical research efforts.
Interview with Michael A Swit, Esq., FDA Lawyer
Mr. Swit has been addressing critical FDA legal and regulatory
issues since 1984. Before joining Duane Morris LLP, Mr. Swit served for
seven years as vice president at a preeminent scientific and FDA
regulatory consulting firm, where he developed and ensured execution of a
broad array of regulatory and other services to clients, both directly
and through outside counsel.
His multi-faceted experience includes serving for three and a half
years as corporate vice president, general counsel and secretary of Par
Pharmaceutical, a prominent, publicly-traded, generic drug company and,
thus, he brings an industry and commercial perspective to his work with
FDA-regulated companies. While at Par, he spearheaded Par's successful
response to multiple federal and state criminal and civil investigations
arising out of the actions of prior management. Mr. Swit then served
for over four years as CEO of FDAnews.com, a premier publisher of FDA
regulatory newsletters and other specialty information products for the
FDA-regulated community. His private FDA regulatory law practice also
has included service as counsel in the FDA practices of three
international law firms, as well as a solo FDA practitioner.
Mr. Swit has taught and written on a wide variety of subjects
relating to FDA law, regulation and related commercial activities,
including, since 1989, co-directing a three-day intensive course on the
generic drug approval process and editing a guide to the generic drug
approval process, Getting Your Generic Drug Approved. A former member of
the Food & Drug Law Journal Editorial Board, Mr. Swit also has been
a prominent speaker at numerous conferences sponsored by such
organizations as the Food & Drug Law Institute (FDLI), the
Regulatory Affairs Professionals Society (RAPS), and the Drug
Information Association (DIA).
Mr. Swit is a 1982 graduate of Emory School of Law and a magna cum
laude graduate of Bowdoin College (1979), with high honors in history.
Checks should be payable to MetricStream Inc. (our parent company). and mailed to:
2600 E. Bayshore Road
Palo Alto, CA 94303
Send Your Team for Maximum Benefit
Get your team up to speed!
Significant tuition discounts are available for teams of two or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount.
Get 10% off
3 to 6 Attendees
Get 20% off
7 to 10 Attendees
Get 25% off
Get 30% off
Call Toll Free +1-888-717-2436 if you have any queries.
Register by Wire Transfer
If you wish to pay by wire transfer: Please call us at Toll Free +1-888-717-2436
Terms & Conditions to register for the Seminar/Conference/Event
Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ email@example.com
Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)
Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future ComplianceOnline event and a credit note will be issued.
Substitutions may be made at any time. No-shows will be charged the full amount.
We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.
In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.
Attendance confirmation and Documents to carry to the seminar venue:
After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.
Conference photograph / video:
By registering and attending ComplianceOnline conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by ComplianceOnline for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline for any kind of claims arising out of copyright or privacy violations.
Schaumburg, IL (Venue to be announced shortly)
September 11-12, 2014
What past attendees say about ComplianceOnline Seminars
I thoroughly enjoyed the seminar! The content of the seminar was excellent. - Associate Director, Pfizer Global Supply
ComplianceOnline is doing well with organizing seminars and webinars. - Associate Director, Dr Reddy's Laboratories
Seminar was very good, informative and a lovely speaker making a tedious topic interesting. Overall the subjects are well chosen and the program was well organized and coordinated. - Director - Global IT Governance, Perrigo
The seminar is good. ComplianceOnline is doing well with organizing seminars and webinars. - Associate Director, Dr Reddy's Laboratories
The event was really well organized and ComplianceOnline staff helped make it a smooth process from initial registration, hotel bookings and seminar materials and stationery. I will be asking my company to send more employees to attend ComplianceOnline seminars. - Legal Advisor
I've attended quite a few seminars by different training providers but ComplianceOnline was by and far the best - the courses are well designed and up to date with the latest developments and the support staff are always helpful, ready to answer your queries. - Chief Executive Officer
The instructor was not only active and helpful during the seminar and workshop, but was available to answer resulting queries after the event as well. - Vice President
I think ComplianceOnline seminars are value for money - the instructors are well prepared and ready to go beyond and above the call of duty to answer even the most complicated of queries regarding subject. - Internal Auditor
Really good location with good lunch. This seminar was full of valuable topics. - System Admin, IT
This is my first experience with ComplianceOnline and I would definitely attend other seminars. - Business System Analyst
It was a very well organized in terms of course, venue and speaker. The content was complete and extremely interesting and I would definitely recommend this seminar to my co-workers.
ComplianceOnline has chosen a very good venue.
- Regulatory Advertising Officer, Health Canada
Interaction between the speaker and audience was interesting. - DVM, Merial
This was tremendously informative and very full of interesting insights. I especially enjoyed going over the warning letters. - Program Manager, Regulatory Affairs, Genentech, Inc.
Instructor is experienced and was willing to share his experiences. - Marketing Manager, Minerva Surgical, Inc
Seminar covered more latest up- to- date information. - Regulatory Affairs Specialist, AccessClosure, Inc
Michael has a good accessible presentation style and was very colloquial. He welcomes questions from attendees and has the answers also. He also promoted good interaction between attendees.
- Sr. Counsel, Siemens Medical Solutions USA, Inc
I had registered for a seminar but unfortunately I was not able to attend. The company was very understanding and extremely helpful. I plan on attending a future event soon. - Director of Regulatory Affairs, Nickell Physician & Pharmacy Services
Entertainment complex. Enjoy games, food, drinks and music. Featuring Steven Spielberg's new virtual reality game Sky Pirates where participants are strapped and experience the physical consequences of their performance in the game.
Spring Valley Nature Sanctuary Schaumburg
A seemingly endless amount of walking and hiking paths work their way through over 135 acres of forest, prairies and wetlands. The sanctuary is home to a farmhouse dating back to 1880 that has been filled with exhibits and artifacts about that period of time.
Atcher Island Waterpark Schaumburg
This theme water park has water slides, a unique circular drop slide, children’s spray ground and more. The park also has a concession and children's playground.
Medieval Times Dinner & Tournament
European style castle housing a 1426 seat theater-style Arena. Dine on a four course medieval meal and watch knights in shining armor compete in jousting.
Trickster Gallery is an extension of the American Indian Center of Chicago. It is the only non-profit Native operated arts institution in the State of Illinois and is dedicated to providing space for first-voice arts. Trickster Gallery features contemporary Native art (post 1960s) and augments exhibits with film screenings, featured speakers, panel discussions, school tours and educator workshops.
Volkening Lake Schaumburg
Walking paths wind their way through the park and down the banks of Volkening Lake. Visitors can fish and rent paddle boats or canoes in lake. Throughout the park a variety of flowers and gardens line the pathways. A small concession stand sells food and beverages.
The Sport Center
This 100,000 sq. ft. indoor sports center features basketball courts, soccer fields, baseball/softball diamonds and a gymnastic facility. Practice and training areas can be rented here.