Wednesday, December 23, 2015

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

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