DTC involves various platforms to convey a message, social media, broadcast media, print media and the internet. Each of these platforms have special criteria to define what you can and cannot do. FDA treats those criteria in a stringent manner. FDA "trolls" these platforms to catch firms running fowl of the FDA's guidance on DTC. If they catch you, they can.
FDA applies principles of cognitive psychology to determine what and how a firm communicates consciously and unconsciously. Firm's that do not understand FDA's regulatory approach to DTC can be costly if you trip one of FDA's legal snares for labeling. This webinar will bring attendees up to speed so you are clearer about when DTC advertising makes you ripe for picking by the FDA.
Why should you Attend: You will learn how to navigate FDA's interpretations and expectations about a firm's DTC marketing practices. Applying a various guidance documents becomes a new test of the FDA's legal boundaries and enforcement options. The agency now applies the principles of cognitive psychology to determine what your message really conveys, whether you meant to or not.
This webinar will provide insight on how to manage your marketing activity when you use DTC advertising and gauge the regulatory risks you face. Attendees will see how a firm's regulatory profile requires cooperation among corporate divisions, such as marketing, regulatory affairs, legal counsel, manufacturing and finance departments. Typically, these divisions work together like oil and water. You will understand that a weak link in any department leaves the entire corporation vulnerable to FDA enforcement. And above all, attendees will also begin to apply the boundaries the FDA uses now and understand how easy it is to promote yourself into a corner.
Areas Covered in the Session:
FDA's approach to DTC advertising and promotion principles
FDA guidance and use of cognitive psychology
Types of violation for illegal DTC advertising practices
Roll of sales and marketing departments
Executives' legal liability
Who Will Benefit:
Sales and marketing executives
Owners and managers of new firms
Own label distributors
International trade managers
Product specification developers
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.