Post by DuVal & Associates, PA

Join Bryan Feldhaus and Regulatory Affairs Professionals Society (RAPS) on May 14th! On-Label, Extra-Label, and Off-Label: Strategizing Medical Device Communications under FDA Regulations and Guidance (The Musical Edition) This workshop is intended for regulatory, compliance and marketing professionals as well as medical device executives, that need to better understand and navigate FDA expectations for medical device communications. It will provide comprehensive coverage of the regulatory landscape governing medical device marketing and sales, including on-label, extra-label, and off-label communications under the Food, Drug, & Cosmetic Act and FDA guidance. Through real-world case studies (including the Vascular Solutions/Howard Root—MN CEO) and Acclarent/Bill Facteau (CEO) and Pat Fabian (VP Sales) criminal prosecutions as well as the recent Gilead/Novartis enforcement actions), interactive exercises, and practical decision-making frameworks, participants will learn to apply established principles for managing medical device communications. Through this session, participants will collaborate on hypotheticals, review sample claims, and refine decision trees and risk evaluations for medical device communications. Dinner will be provided by DuVal & Associates 🍽️ REGISTER HERE: https://lnkd.in/gJQ7-MFh