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Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices: 2-day In-person Seminar

By:
Michael A Swit, Esq., FDA Lawyer
Location:-
Courtyard Marriott Boston - Cambridge, MA
| Thursday, November 6, 2014 | Friday, November 7, 2014

Course "Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Course Description:

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.



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.

Interview with
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:

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




COURSE OUTLINE:

DAY ONE (8:30 AM – 4:30 PM) DAY TWO (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

    I. Understanding the Basics
    1. Who Has Jurisdiction
      1. Drugs & Biologics
        1. Rx Drug Advertising
        2. OTC Drug Advertising
      2. Devices
        1. Restricted
        2. all other
    2. Labeling vs. Advertising
    3. Basic drug rules
      1. Fair balance
    4. Device rules
      1. Intended use deviations
    5. DTC advertising
      1. Print
      2. TV
    6. Comparative Claims
      1. standard to support
      2. push to pursue CER
    7. Detailing and Sampling
      1. is there still a future?
      2. what can be said?
      3. danger of “custom” pieces
    8. How FDA learns of violations
      1. Keep your house clean or your competitors will rat you out

    II. Scientific Exchange
    1. Guidances on Dissemination of Scientific Information
    2. Risks involved in Off-Label Statements
    3. Procedural Requirements and Unsolicited Requests for Information

    III. First Amendment
    1. Understanding “Commercial Speech” Doctrine
    2. FDA and the Regulation of Advertising

    IV. Websites & Social Media
    1. FDA Policies on the Internet
    2. Recent FDA Enforcement Activities
    3. How to Handle at the Company Levels

    V. Enforcement Trends
    1. FDA Hot Buttons
      1. Understating risk
      2. Overstating effectiveness
    2. FTC
      1. POM Wonderful and substantiation
    3. Private Litigation – Understanding
      1. Lanham Act
      2. State Unfair Competition

    VI. False Claims Act and Criminal Liability
    1. Review of Key Settlements
    2. “Responsible Corporate Official” Liability

    VII. Handling at the Company Level
    1. Compliance Programs
    2. Internal processes




Meet Your Instructors

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.
 
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.





Register Online

$1,599.00

Seminar One Registration

November 6-7, 2014, Cambridge, MA

$7,299.00
$9,594.00
You Save: $2,295.00 (23%)*

Special Group Discount Register for Six attendees

November 6-7, 2014, Cambridge, MA
*Hurry! This option is limited and based on availability.
Great Savings with Group Ticket!!! Only 3 left


Price $1,599

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.

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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 @ editor@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 $200 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 ($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.

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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.

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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.

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Venue

Location:

Special Offer for the attendees of this seminar:

Rooms available at only $259 per night.

Please note: Hotel rooms are limited and based on availability.




View Larger Map


How to Reach

General Driving Directions:

From Boston Logan International Airport – BOS: 7.3 mile(s) W
  • Exit Airport and take MassPike (I-90) West to Exit 20 (Cambridge)
  • Continue straight and cross bridge
  • Take first right after bridge onto Memorial Drive
  • Hotel is 200 yards ahead on the left.

From Manchester-Boston Regional Airport – MHT: 55.1 mile(s) SE
  • Follow I-293 to I-93S towards Boston
  • Take exit 26B (Storrow Drive West) and continue for 3 miles
  • Bear right at the Central Square/MassPike exit and turn right at the light
  • After crossing the bridge, take first right onto Memorial Drive and Hotel is on the left.

From T F Green Airport – PVD: 62.1 mile(s) NE
  • Take I95N to I93N
  • Then, take exit 26 (Storrow Drive West) and follow Storrow Drive
  • Take the Central Square/MassPike exit and turn right at light
  • After crossing the bridge, take first right onto Memorial Drive and Hotel is on the left.

Other Transportation:

Bus Station
  • South Station: 5 mile(s) SE

Subway Station
  • B.U. Central (on the Green Line): 0.8 mile(s) SE
  • Central Station (on the Red Line): 0.8 mile(s) NE

Train Station
  • Back Bay Station (BBY): 3 mile(s) SE
  • South Station (BOS): 5 mile(s) SE

Disclaimer: Directions to the venue above have been taken from the hotel website. ComplianceOnline is not responsible for any inaccuracies in the same. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue.





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

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





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  • Article on the magazine and/or website after the conference.

 




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