Enforcement Basics and Advanced Enforcement Applications

Session 1: Enforcement Basics | Download Slides
This interactive session will cover “what to do when the government shows up at your door.”

Gary Bird, President, PharmaConsult-US

Lori Hirsch, Managing Counsel, Merck & Co., Inc.

LCDR Collins Mason, Supervisory Investigator, Baltimore District, FDA

 Amra Racic, Principal Regulatory Affairs Policy and Advocacy Specialist, Medtronic PLC

Moderated by Nancy Singer, President, Compliance-Alliance, LLC

Session 2: Advanced Enforcement Applications | Download Slides
This session will focus on a range of complex issues, including sunshine act reporting, OCI investigations, and what recent trends in enforcement may mean for your industry.

Brian Dahl, Principal, Dahl Compliance Consulting LLC

Sarah diFrancesca, Attorney, Cooley, LLP

James Flaherty, Associate General Counsel - FDA Regulatory, Fresenius Medical Care North America

Beth Weinman, Associate Chief Counsel for Enforcement, Office of Chief Counsel, FDA

Moderated by Neil DiSpirito, Partner, Olsson Frank Weeda Terman Matz PC