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    6-Hour Virtual Seminar on FDA Scrutiny of Promotion and Advertising Practices

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    Website https://www.globalcompliancepanel.com/virtual-seminar/6-hour-virtual-seminar-on-fda-scrutiny-of-prom | Want to Edit it Edit Freely

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    Deadline: June 17, 2020 | Date: June 17, 2020

    Venue/Country: Online event, U.S.A

    Updated: 2020-05-25 20:54:45 (GMT+9)

    Call For Papers - CFP

    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.

    Why you should attend

    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:

    Learn how FDA faces constitutional constraints on enforcement decisions

    Learn about intersecting federal requirements by the Department of Justice, the Federal Trade Commission, the Securities and Exchange Commission and the Consumer Product Safety Commission

    Learn how the FDA interprets advertising and promotion in principle and in fact

    Understand ways that a firm violates FDA requirements

    Evaluate advertising and promotional material based on interactive group hypotheticals

    See how sales and marketing departments play a central role, for better or worse

    Learn how the federal government holds executive management responsible for missteps in promotion and advertising practices

    Who Will Benefit

    Sales and Marketing executives and managers

    Regulatory Managers

    In-house Legal Counsel and Contract Specialists

    3rd party consultants

    Venture Capitalists

    Investors

    Business Acquisition Executives

    Owners of New or Developing Firms

    Own label distributors

    International Trade Managers

    Product specification developers

    https://www.globalcompliancepanel.com/virtual-seminar/6-hour-virtual-seminar-on-fda-scrutiny-of-promotion-and-advertising-practices-11457LIVE?ourglocal-seo


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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