Date :
Place : United States, San Francisco
Contact Person:Event Manager
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.Deadline for abstracts/proposals : 17th January 2019
Organized By :NetZealous LLC - DBA GlobalCompliancePanel
Keynote Speakers : 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
Conference Highlights :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
Venue :Hilton San Francisco Airport Bayfront, Airport Boulevard, Burlingame, CA, USA
Check the event website for more details.