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    FDA Scrutiny of Promotion and Advertising Practices

    Start Date : October 11, 2018
    End Date : October 12, 2018
    Time : 9:00 am to4:30 pm

    Phone : (800) 447-9407
    Email : globalcompliancepanel@gmail.com

    Location :
    Hilton San Francisco Airport Bayfront 600 Airport Blvd, Burlingame, CA 94010, USA

    Website

    Description


    Course “FDA Scrutiny of Promotion and Advertising Practices” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

    Description:

    If you go “off label” with advertising and promotion, FDA’s hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments must collaborate to avoid the hammer and penalties of FDA. The roadblock, however is that marketing managers and regulatory affairs managers rarely reach common ground and are loathe to even consult with each other.

    FDA’s Center for Devices and Radiological Health (CDRH) has never issued a comprehensive guidance on advertising and promotion. You are on your own. In contrast, FDA’s Center for Drug Evaluation and Research (CDER) uses long-standing regulations and a growing number of guidance documents in its regulatory approach. Policing social media has become a new regulatory responsibility and FDA is still trying to figure out how to deal with it. Bottom line, do you know when you fail to meet FDA’s requirements or are you guessing? Can you afford to guess? The cost to your business and the confusion left in your customers’ mind becomes an unwelcomed nightmare.

    In this seminar, you will learn how to navigate FDA’s numerous legal options and how to interpret them based on basic legal principles. Applying new guidance documents becomes a new test of the FDA’s legal boundaries and enforcement options. The agency is now conducting clinical studies and applies the principles of cognitive psychology to aid in its determination of what a message really conveys. This academic discipline may or may not get to the root of what consumers take away as the message.

    Congress and the new FDA Commissioner seem more sympathetic to expanding access to medical treatment before all the conclusive evidence for safety and effectiveness is evaluated by the FDA. Valid off-label information may take the lead in that direction.

    This conference will provide insight on how to manage your marketing activity and gauge what regulatory risks your business is willing to accept. You will learn how corporate management requires cooperation between marketing, regulatory affairs, legal counsel, manufacturing, engineering and finance departments. Operating in a stovepipe environment will not work. You need to understand that a weak link in any department leaves the entire corporation vulnerable to FDA enforcement. Most importantly, you will understand the boundaries that FDA uses and how easy it is to cross them. With information from this course, you can step back and rationally evaluate your firm’s regulatory profile for advertising and promotion practices.


    Learning Objective:

    Who Will Benefit:

    Background

    FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. The vehicle for communication has evolved dramatically over the past 100 years and continues to evolve at a rate faster than one can anticipate at times. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the legal field playing field involves other federal agencies and departments, and they work in concert with FDA. It has become very complicated and very costly if you knowingly or unknowing walk into a legal snare. This seminar is designed to bring you up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.

     

    Agenda:

    Day 1 Schedule


    8:30 AM – 9:00 AM: Registration


    9:00 AM – 10:30 AM

    Lecture 1: FDA legal authority

    Cognitive psychology vs. psychoanalytic motivation


    10:30 AM – 12:00 PM

    Lecture 2: Promotion and Advertising: scope of labeling


    12:00 PM – 1:00 PM Lunch


    1:00 PM – 2:30 PM

    Lecture 3: Supreme Court / commercial free speech

    Policy


    2:30 PM – 2:45 PM Break


    2:45 PM – 4:30 PM

    Hypothetical Workshop

     Day 2 Schedule


    9:00 AM – 10:30 AM

    Lecture 1: 
    Direct to consumer advertising vectors 
    Federal Trade Commission interest (economic vs. safety) 
    Context and format of messaging 
    Script versus message


    10:30 AM – 12:00 PM

    Lecture 2: False and misleading information


    12:00 PM – 1:00 PM Lunch


    1:00 PM – 2:30 PM

    Lecture 3: 
    Off label use – practices and policy
    FDA Warning Letters


    2:30 PM – 2:45 PM Break


    2:45 PM – 4:30 PM

    Lecture 4: 
    Practice of medicine exemption
    Custom Device promotion 
    (Group Hypothetical) 
    Corporate management responsibility

    Speaker:

    Casper Uldriks

    ex-FDA Expert and former Associate Center Director of CDRH

    Casper (Cap) Uldriks owns Encore Insight LLC, which provides consulting services on FDA Law. He brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and as an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He understands how FDA thinks, operates and where it is headed.

     

    Location:  SFO, CA Date: October 11th & 12th, 2018 and Time: 9:00 AM to 4:30 PM

    Venue:  Hilton San Francisco Airport Bayfront   600 Airport Blvd, Burlingame, CA 94010, USA

     

    Price:

    Price: $1,295.00 (Seminar Fee for One Delegate) Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)* Register now and save $200. (Early Bird)

    Sponsorship Program benefits for seminar

    For More Informationhttps://www.globalcompliancepanel.com/control/sponsorship

    Contact us today!

    NetZealous LLC DBA GlobalCompliancePanel

    john.robinson@globalcompliancepanel.com

    Toll free: +1-800-447-9407

    Phone: +1-510-584-9661

     Website: http://www.globalcompliancepanel.com

     

    Registration Link – https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901420SEMINAR?seo

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    Registration Info

    https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901420SEMINAR?meetings4docs-oct-seo

    Contact the Organizer

    Organized by

    Organized by globalcompliancepanel

    NetZealous LLC DBA GlobalCompliancePanel ,
    161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.

    GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.

    GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place.

    GlobalCompliancePanel focuses primarily on providing extensive and quality training in these core areas and anything related to them:

    • Risk Management
    • Regulatory Compliances
    • Corporate Governance
    • Quality Management
    Tel: 800-447-9407
    Email: globalcompliancepanel@gmail.com
    Website: https://www.globalcompliancepanel.com/


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