6-Hour Virtual Seminar on FDA's Moving Target and Hammer for Social Media

Duration: 6 hours
FDA's regulation of Social media operates with a moving target. What is OK or not OK remains vague, perhaps purposely so. All social media platforms provide common ways to cross FDA's legal boundaries, whether you do it knowingly or unknowingly. How you salvage your regulatory posture needs a clear corporate policy, procedures and effective implementation. As information increases with technology, FDA will need to analyze what works and what does not from a practical point of view. Policing social media has become a new regulatory responsibility and FDA is still trying to figure out how to deal with it. FDA has a weak legal history on this topic. Federal courts keep pushing back the Constitutionality of FDA's enforcement actions. The problem is that no one can figure out a clear future for FDA and for themselves. Unfortunately the cost to your business and the confusion left in your customers' mind becomes an unwelcomed nightmare.
FDA’s Regulation of Social Media
Instructor: Casper E Uldriks
Product ID: 505151
This 6hr virtual seminar 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.

Objectives of the Presentation
  • How Social Media Becomes Your Speech
  • How Commercial Speech vs. Free Speech is Regulated
  • Understand How Direct-to-Consumer Information makes you a target
  • Differentiating the Dynamics and Boundaries of Information Requests
  • Identify Executive Corporate Management Liability
  • Analyze Conflicting Statutory and Case Laws
Why Should you Attend
FDA regulates how firms advertise and promote their products in social media and creates a regulatory risk of enforcement action when firm's step over FDA's somewhat mysterious advertising and promotion boundaries. What you or someone else says about your product, whether true, false or misleading, becomes a target for FDA's legal hammer. FDA can levy fines, issue Warning Letters and even an injunction or prosecution end up creating a corporate crisis and confusing your customers or driving them away. A single 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.

Areas Covered
  • Constitutional Protection of Commercial Free Speech
  • Scope of Labeling
  • FDA Policy and Enforcement
  • Social Media Use
  • Direct-to-Consumer Intended Use Problems
  • Education Information Alternatives
  • Overlapping Federal Laws
  • Corporate Management's Legal Responsibility and Liability
Who will Benefit
  • Regulatory Affairs Director
  • Sales and Marketing executives and managers
  • Marketing Director
  • Quality Assurance Manager
  • Clinical Study Sponsors and Clinical Investigator
  • Medical Director
  • Operations Finance Managerss
  • Complaint Department Manager
  • Recall Managers
  • In-house Legal Counsel
  • Sales Staff
  • Customer Support Staff
  • Contract Specialists
  • 3rd party consultants
  • Owners of New or Developing Firms
  • Own label distributors
  • Venture Capitalists & Business Acquisition Executives
  • Manufacturers of food, drugs, cosmetics, devices and biologics
$600
Recorded Session for one participant
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  $700.00 Training CD
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  $800.00 Training USB Flash Drive
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Mr. Uldriks held a number of positions at FDA, such as an investigator in FDA's New England office, in the Office of the Commissioner in Legislative Affairs and in the Center for Devices and Radiological Health (CDRH), where he served as CDRH's Associate Director for Regulatory Guidance and Government Affairs. He helped to guide CDRH to develop and implement various medical device related amendments to the Food, Drug, and Cosmetic Act, regulations and guidance documents. For years he has trained FDA staff on medical law and has been a featured speaker at many professional conferences involving FDA's medical device program.
Bar Admissions: Massachusetts, 1986 and District of Columbia, 2011
Education: Suffolk University Law School, Boston, Massachusetts, 1986.
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