Responsibility for Off-label Claims in Social Media
Register for this event
- DateWed 22 April 2020
- Time10:00 AM - 1:30 PM
- VenueOnline event
- LocationOnline United States National 9453
- Ticket$$150 per person
- Table$Price for a table per table (seats Normally between 8-12)
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
If the information can reach a consumer, FDA cares, even if you did not publish the information. Firm's need to watch for promotional trespassers. Websites, chat rooms, op-ed articles or even your own postings in social media can cause your product to be misbranded, i.e., illegal.
One big issue is how you patrol and control what someone else is saying about your product in a public forum. Once the off-label information is out there, what is scope your responsibility?
Why you should Attend:
What is considered "off-label"
Using social media website "likes" and links
Direct to Consumer promotion pitfalls
Fair and balanced information
Areas Covered in the Session:
Understand how social media is labeling
Learn how third parties place you in jeopardy
Understand FDA's concern about "fair and balanced" information
Ways to define your social media responsibilities
Apply FDA Guidance Documents on DTC / social media labeling
Who Will Benefit:
Regulatory Affairs Directors
Quality Assurance Managers
Casper (Cap) Uldriks, through his firm "Encore Insight LLC," 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 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. His comments are candid, straightforward and of practical value. He understands how FDA thinks, how it operates and where it is headed.
Based on his exceptionally broad experience and knowledge, he can synthesize FDA's domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture. Professional credentials: JD - Suffolk University, licensed in Massachusetts and the District of Columbia; M.Div in psychology - Boston University with internship through Harvard University.
NetZealous LLC DBA-Compliance4all