Wednesday, December 16
12:25 – 12:30 PM
Laura Brown, Director, Educational Programs, FDLI
Address: Eighth Annual Eric M. Blumberg Memorial Lecture
John M. Taylor, President and Principal, Compliance and Regulatory Affairs, Greenleaf Health, Inc.
Global Supply Chains: Current Issues and Managing Risk
Stefanie Jill Fogel, Partner, DLA Piper LLP (US)
Jonathan Gil, Corporate Counsel, Pfizer, Inc.
Moderated by Howard R. Sklamberg, Partner, Arnold & Porter LLP
Concurrent Breakout Sessions
- FDA Inspections in the Age of COVID-19
Philip Crooker, Vice President – Technical, Parexel International Corporation
Stephanie M. Haggerty, Senior Corporate Counsel, Legal Division, Pfizer, Inc.
Anne K. Miller, Senior Principal Legal Counsel, Medtronic
Moderated by Cathy L. Burgess, Partner, Alston & Bird LLP and Member, FDLI Board of Directors
- Digital Health: Enforcement, Regulations, and Risks
Christine P. Bump, Principal, Penn Avenue Law & Policy
Mahnu Davar, Partner, Arnold & Porter LLP
Fred Medick, Senior Corporate Counsel, Healthcare Law Group, Genentech, Inc.
Vernessa T. Pollard, Partner, McDermott Will & Emery LLP
- Hot Button Issues and Trends in State and Local Government Tobacco Regulation and Enforcement
Beth G. Oliva, Partner, Fox Rothschild LLP
Agustin Rodriguez, Counsel, Troutman Pepper Hamilton Sanders LLP
Cheryl Sbarra, Executive Director and Senior Staff Attorney, Massachusetts Association of Health Boards
Kevin R.J. Schroth, Associate Professor, Department of Health Behavior, Society and Policy, Rutgers University School of Public Health
Concurrent Breakout Sessions
- Quality Risk Management (QRM) During a Pandemic and After: Essential Components of Risk Management During a Public Health Crisis
Barbara Allen, Senior Director, Global Quality External Engagement, Eli Lilly and Company
Dennis C. Gucciardo, Partner, Morgan, Lewis & Bockius LLP
Danielle Humphrey, Associate General Counsel, Regulatory Law and Compliance Office, Becton Dickinson
Frances Zipp, President & CEO, Lachman Consultants
- Regenerative Medicine: Policy, Innovation, and Risk Management for Emerging Technologies
Amy Garabedian, Associate General Counsel, Spark Therapeutics
Preeya Noronha Pinto, Partner, King & Spalding LLP
Collin Stabler, Senior Associate, Exponent, Inc.
Julia C. Tierney, Chief of Staff, CBER, FDA
- Other Agencies: FTC and SEC Litigation, Enforcement, and Application to FDA Authorities
Richard Cleland, Assistant Director, Bureau of Consumer Protection, Division of Advertising Practices, Federal Trade Commission
Theodora (Teddy) McCormick, Partner, Epstein Becker Green, PC
William J. Stellmach, Partner, Willkie Farr & Gallagher LLP
Top Trends and Cases in FDA and DOJ Criminal Enforcement
Hannah R. Bornstein, Partner, Nixon Peabody LLP
William F. Gould, Partner, Holland & Knight LLP
Steven A. Johnson, Vice President – Compliance & Legal Affairs, Zogenix, Inc.
Shannon Pedersen, Trial Attorney, Consumer Protection Branch, Department of Justice
Closing Remarks and Adjournment