ComplianceOnline

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.

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Learning Objectives:

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 drug companies
  • 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.

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:

  • Sales
  • Marketing
  • Medical Affairs
  • Legal
  • Regulatory
  • Compliance

Interview with

Michael A Swit, Esq., FDA Lawyer
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(8:30 AM - 4:30 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • I. Understanding the Basics
    • Who Has Jurisdiction
      • Drugs & Biologics
        • Rx Drug Advertising
        • OTC Drug Advertising
      • Devices
        • Restricted
        • all other
    • Labeling vs. Advertising
    • Basic drug rules
      • Fair balance
    • Device rules
      • Intended use deviations
    • DTC advertising
      • Print
      • TV
    • Comparative Claims
      • standard to support
      • push to pursue CER
    • Detailing and Sampling
      • is there still a future?
      • what can be said?
      • danger of “custom” pieces
    • How FDA learns of violations
      • Keep your house clean or your competitors will rat you out
  • II. Scientific Exchange
    • Guidances on Dissemination of Scientific Information
    • Risks involved in Off-Label Statements
    • Procedural Requirements and Unsolicited Requests for Information
  • III. First Amendment
    • Understanding “Commercial Speech” Doctrine
    • FDA and the Regulation of Advertising
  • IV. Websites & Social Media
    • FDA Policies on the Internet
    • Recent FDA Enforcement Activities
    • How to Handle at the Company Levels
Day 02(8:30 AM - 4:30 PM)
  • V. Enforcement Trends
    • FDA Hot Buttons
      • Understating risk
      • Overstating effectiveness
    • FTC
      • POM Wonderful and substantiation
    • Private Litigation – Understanding
      • Lanham Act
      • State Unfair Competition
  • VI. False Claims Act and Criminal Liability
    • Review of Key Settlements
    • “Responsible Corporate Official” Liability
  • VII. Handling at the Company Level
    • Compliance Programs
    • Internal processes
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Michael A Swit, Esq.

Michael A Swit, Esq.
FDA Lawyer

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.

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.

Interview with

Michael A Swit, Esq., FDA Lawyer
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Register Now

Online using Credit card

$1,299.00

Seminar One Registration

July 26-27, 2018, Chicago, IL
(Registrations till July 3, 2018 - $1299)
(Registrations after July 3, 2018 - $1699)

$5,999.00
$7,794.00 (23%)*

Save $1,795.00

Special Group Discount Register for Six attendees

July 26-27, 2018, Chicago, IL
*Hurry! This option is limited and based on availability.
Great Savings with Group Ticket!!! Only 3 left




The registration fee includes: the workshop; all related course materials; morning tea/coffee with cookie; lunch, on both the days.


For discounts on multiple registrations, contact customer care at +1-888-717-2436.

Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
2479 East Bayshore Road Suite 260
Palo Alto, CA 94303
USA

By Wire -

Register / Pay by Wire Transfer

Please contact us at +1-888-717-2436 to get details of wire transfer option.

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 @ customercare@complianceonline.com

Payment:
Payment is required 2 days before 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 $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) 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 5 working days before 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 ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

Offers:

  • Early bird seats are limited and based on first-come, first-serve.
  • Multiple offers cannot be combined.
  • Location:

    Chicago, IL
    (Venue to be announced shortly)

    July 26-27, 2018

    Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

    Testimonials

    What past attendees say about ComplianceOnline Seminars

    I wanted to let you know that the speaker for this program (Michael Swit) was exceptional. He was professional, efficient, and went out of his way to help the attendees. Thank you.

    Medical Director,

    Depomed, Inc

    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

    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

    Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

    We are pleased to offer several exhibitor, sponsorship and media partnership options designed to maximize your company's exposure and networking opportunities before, during and after the event.

    Benefits of becoming a Sponsor/Exhibitor/Media Partner:

    • Logo on website, marketing email, branding materials & the registration booth
    • Exhibit Space
    • Free event pass
    • Speaking opportunity
    • Social media campaign

    For more details and other sponsorship options at this event, please contact Event Manager: customercare@complianceonline.com or call: +1-650-238-9656

    Media Partner:

    Media Partner

    Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

    Local Attractions of Chicago, IL

    Windy

    Windy

    One of the more breathtaking scenes on the lake is this tall ship approaching the docks at Navy Pier. The 148-foot four-masted schooner (and its new sister ship, the Windy II ) sets sail for 90-minute cruises two to five times a day, both day and evening. (Because the boats are sometimes booked by groups, the schedule changes each week; call first to confirm sailing times). The boats are at the whims of the wind, so every cruise charts a different course. Passengers are welcome to help raise and trim the sails and occasionally take turns at the ship's helm (with the captain standing close by). The boats are not accessible for people with disabilities.

    Adler Planetarium and Astronomy Museum

    Adler Planetarium and Astronomy Museum

    The building may be historic (it was the first planetarium in the Western Hemisphere), but some of the attractions here will captivate the most jaded video-game addict.
    Your first stop should be the modern Sky Pavilion, where the don't-miss experience is the StarRider Theater. Settle down under the massive dome, and you'll take a half-hour interactive virtual-reality trip through the Milky Way and into deep space, featuring a computer-generated 3-D-graphics projection system and controls in the armrest of each seat. Six high-resolution video projectors form a seamless image above your head -- you'll feel as if you're literally floating in space. If you're looking for more entertainment, the Sky Theater shows movies with an astronomical bent; recent shows have included Secrets of Saturn and Mars Now!

    Arlington International Racecourse

    Arlington International Racecourse

    With its gleaming-white, palatial, six-story grandstand and lush gardens, this racecourse is one of the most beautiful showcases for thoroughbred horse racing in the world. Its storied history stretches back to 1927, and such equine stars as Citation, Secretariat, and Cigar have graced the track. The annual Arlington Million (the sport's first million-dollar race, held in mid-Aug) attracts top jockeys, trainers, and horses and is part of the World Series Racing Championship, which includes the Breeders Cup races. Arlington's race days are thrilling to behold, with all of racing's time-honored pageantry on display -- from the bugler in traditional dress to the parade of jockeys.

    Art Institute of Chicago

    Art Institute of Chicago

    You can't -- and shouldn't -- miss the Art Institute. (You really have no excuse, since it's conveniently located right on Michigan Ave. in the heart of downtown.) No matter what medium or century interests you, the Art Institute has something in its collection to fit the bill. Japanese ukiyo-e prints, ancient Egyptian bronzes, Greek vases, 19th-century British photography, masterpieces by most of the greatest names in 20th-century sculpture, and modern American textiles are just some of the works on display, but for a general overview of the museum's collection, take the free "Highlights of the Art Institute" tour Saturday and Sunday.

    Auditorium Building and Theatre

    Auditorium Building and Theatre

    A truly grand theater with historic-landmark status, the Auditorium gives visitors a taste of late-19th-century Chicago opulence. Because it's still a working theater -- not a museum -- it's not always open to the public during the day; to make sure you'll get in, schedule a guided tour, which are offered on Mondays at 10am and noon.
    Designed and built in 1889 by Louis Sullivan and Dankmar Adler, the 4,000-seat Auditorium was a wonder of the world: the heaviest (110,000 tons) and most massive modern edifice on earth, the most fireproof building ever constructed, and the tallest building in Chicago. It was also the first large-scale building to be lit by electricity, and its theater was the first in the country to install air-conditioning. Originally the home of the Chicago Opera Company, Sullivan and Adler's masterpiece is defined by powerful arches lit by thousands of bulbs and features Sullivan's trademark ornamentation -- in this case, elaborate golden stenciling and gold plaster medallions. It's equally renowned for otherworldly acoustics and unobstructed sightlines.

    Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

    We need below information to serve you better

    Best Sellers
    You Recently Viewed
      Loading