AGENDA
Renaissance Washington, DC Downtown Hotel
999 9th Street, NW
Washington, DC 20001
999 9th Street, NW
Washington, DC 20001
Monday, December 8, 2014
8:00 – 8:45 AM
Registration and Continental Breakfast
8:45 – 9:00 AM
Welcome and Opening Remarks
Amy Comstock Rick, President & CEO, FDLI
9:00 – 9:45 AM
Keynote Address
Thomas South, Special Agent in Charge of Investigative Operations, Office of Criminal Investigations, FDA
9:45 – 10:45 AM
Compliance Central with FDA Center Compliance Directors (Part I)
Attend Compliance Central to hear directly from FDA officials on compliance issues and goals for 2015.
8:00 – 8:45 AM
Registration and Continental Breakfast
8:45 – 9:00 AM
Welcome and Opening Remarks
Amy Comstock Rick, President & CEO, FDLI
9:00 – 9:45 AM
Keynote Address
Thomas South, Special Agent in Charge of Investigative Operations, Office of Criminal Investigations, FDA
9:45 – 10:45 AM
Compliance Central with FDA Center Compliance Directors (Part I)
Attend Compliance Central to hear directly from FDA officials on compliance issues and goals for 2015.
Michael Levy, Deputy Director, Office of Compliance, CDER
William Correll, Director, Office of Compliance, CFSAN
Daniel McChesney, Director, Office of Surveillance and Compliance, CVM
William Correll, Director, Office of Compliance, CFSAN
Daniel McChesney, Director, Office of Surveillance and Compliance, CVM
Moderated by Lewis Grossman, Professor of Law, American University, Of Counsel, Covington & Burling LLP, and Board Member, FDLI
10:45 – 11:00 AM
Networking Break11:00 AM – 12:00 PM
Compliance Central with FDA Center Compliance Directors (Part II) /Slides
Mary A. Malarkey, Director, Office of Compliance and Biologics Quality, CBER
Steven D. Silverman, Director, Office of Compliance, CDRH
Ann L. Simoneau, Director, Office of Compliance and Enforcement, CTP
Moderated by Lewis Grossman, Professor of Law, American University, Of Counsel, Covington & Burling LLP, and Board Member, FDLI
Lunch
1:15 – 2:30 PM
Concurrent Breakout Sessions: Responding to FDA Enforcement Actions
Session 1: Enforcement Basics / Slides
This high-energy, interactive session will cover “what to do when FDA shows up at your door.” A panel of experts will discuss specific challenges including: Are you obligated to tell FDA when you discover that a staff member has falsified documents; or What does it mean when a national expert mentions that he has recently been to several of your other facilities; or how to respond if an investigator asks you to provide all of your customer complaints back to 2003. Other topics include enforcement statistics, whistle blowers, import detentions, and seizures.
Elaine Messa, President, NSF Health Sciences Medical Devices
Marcela Rios Vessell, Vice President, Global Quality Systems, Manufacturing and Distribution, Integra LifeSciences
Michael Viscido, Corporate Director Quality Systems and Services, IKARIA, Inc.
Mark Mansour, Partner, Jones Day
Marcela Rios Vessell, Vice President, Global Quality Systems, Manufacturing and Distribution, Integra LifeSciences
Michael Viscido, Corporate Director Quality Systems and Services, IKARIA, Inc.
Mark Mansour, Partner, Jones Day
Moderator: Nancy Singer, President, Compliance-Alliance, LLC
This panel will focus on a range of complex issues, including private enforcement actions through state consumer protection laws, the Lanham Act, False Claims Act, deferred prosecution agreements, and non-prosecution agreements. The session will present both the plaintiff and defense side of enforcement actions. Additionally, the panelists will review inspections and warning letters and what FDA enforcement trends may mean for industry members.
John Fuson, Partner, Crowell & Moring LLP
Mitchell Fuerst, Managing Partner, Fuerst Ittleman David & Joseph, PL
Steven M. Kowal, Partner, K&L Gates LLP
Gary Giampetruzzi, Partner, Paul Hastings LLP
Mitchell Fuerst, Managing Partner, Fuerst Ittleman David & Joseph, PL
Steven M. Kowal, Partner, K&L Gates LLP
Gary Giampetruzzi, Partner, Paul Hastings LLP
Moderated by Sonali P. Gunawardhana, Of Counsel, Wiley Rein LLP
2:30 – 2:45 PM
Networking Break
Concurrent Breakout Sessions in Your Industry:
2:45 – 3:30 PM
Session 1: Pharmaceutical and Medical Device Advertising and Promotion
Networking Break
Concurrent Breakout Sessions in Your Industry:
2:45 – 3:30 PM
Session 1: Pharmaceutical and Medical Device Advertising and Promotion
First Amendament Issues and the Future of FDA Regulation / Slides
In this session, panelists will discuss False Claims Act cases regarding advertising and promotion for pharmaceutical and medical devices, as well as advertising pertaining of off-label use. Panelists will then discuss the First Amendment issues surrounding advertising and promotion, as well as pragmatic solutions for future regulation.
Mark Carlisle Levy, Partner, Eckert Seamans Cherin & Mellott, LLC
Jeff Francer, Vice President & Senior Counsel, PhRMA
Jeff Francer, Vice President & Senior Counsel, PhRMA
Moderated by Ivan Wasserman, Partner, Manatt, Phelps & Phillips, LLP
Session 2: What are the Greatest Challenges for Industry Compliance with FSMA, and What are Enforcement Concerns to Keep in Mind? / Slides
During this session, panelists will discuss the challenges for industry compliance with FSMA. Hear from industry on anticipated issues as well as hurdles they have seen thus far leading up to the finalization of the rules, and learn how to obtain and manage information effectively to get and stay in compliance. Panelists will also address the challenges with ascertaining the requirements under FSMA and what this means for compliance, as well as potential legal ramifications.
Charles Breen, Senior Consultant, EAS Consulting Group LLC
Lee Sanders, Senior Vice President, Government Relations & Public Affairs, American Bakers Association
Frederick Stearns, Partner, Keller and Heckman, LLP
3:35 – 4:20 PMLee Sanders, Senior Vice President, Government Relations & Public Affairs, American Bakers Association
Frederick Stearns, Partner, Keller and Heckman, LLP
Session 1: cGMP Enforcement Issues / Slides
Panelists will address different types of enforcement actions that can occur at the different stages during and after an FDA inspection, and what to do in these situations. Stages to be addressed include: during an FDA inspection, upon receiving an FDA warning letter, during a DOJ investigation, during a DOJ resolution, in the case of a consent decree, DOJ injunction, and whistleblower actions.
Neil Di Spirito, Partner, Olsson Frank Weeda Terman Matz PC
David Chesney, Vice President and Practice Lead, PAREXEL Consulting
Marilyn May, Counsel, Arnold & Porter LLP
David Chesney, Vice President and Practice Lead, PAREXEL Consulting
Marilyn May, Counsel, Arnold & Porter LLP
Session 2: Criminal Enforcement in Foods, Cosmetics, and Dietary Supplements: Recent Cases / Slides
Panelists in this session will discuss the most relevant and interesting criminal cases in food, cosmetics, and dietary supplements. Issues and cases to be discussed include: caffeinated clothing, what DOJ looks for in dietary supplement criminal cases, felony convictions stemming from recalls, government focus on prosecution of individuals, and the Peanut Corporation of American case.
Michael Blume, Director, Consumer Protection Branch, DOJ
Angela Spivey, Partner, McGuireWoods LLP
Roseann Termini, Professor, Widener University School of Law
Angela Spivey, Partner, McGuireWoods LLP
Roseann Termini, Professor, Widener University School of Law
What does enforcement discretion mean within FDA in regards to medical devices? This panel will explore medical device enforcement discretion through a discussion of mobile medical applications and data systems, laboratory developed tests, and clinical decision support.
Lauren Silvis, Partner, Sidley Austin LLP
Linda Bentley, Member, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, PC
Lance Shea, Partner, BakerHostetler
Linda Bentley, Member, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, PC
Lance Shea, Partner, BakerHostetler
4:30 – 5:30 PM
International Enforcement and Compliance Initiatives / Slides
Expert panelists will discuss different areas of enforcement and compliance, beginning with FDA enforcement trends for imports. Panelists will also discuss the interplay between FDA and customs, including methods to expedite your product through customs. Other topics for discussion include: the Trusted Trader Program, international compliance issues for medical devices, and pending international agreements, such as the Transatlantic Trade and Investment Partnership.
Leslie Glick, Partner, Porter Wright Morris & Arthur LLP
Jennifer Diaz, Shareholder and Chair, Customs and International Trade Department, Becker & Poliakoff, P.A.
Phil Johnson, Senior Director, Quintiles, Inc.
Moderated by John F. Johnson III, Associate Attorney, FDAImports.com, LLC
Jennifer Diaz, Shareholder and Chair, Customs and International Trade Department, Becker & Poliakoff, P.A.
Phil Johnson, Senior Director, Quintiles, Inc.
Moderated by John F. Johnson III, Associate Attorney, FDAImports.com, LLC
2014 Annual Holiday and Leadership Awards Reception
Tuesday, December 9, 2014
8:30 – 9:00 AM
Continental Breakfast
9:00 – 10:30 AM
Interagency Enforcement Action: An Inside Look
Even the most veteran enforcement professionals are not always privy to how the federal government works across agencies to collaborate on enforcement actions. This panel will provide a unique first-hand perspective from agency officials across the federal government on how they communicate, collaborate, and implement enforcement actions.
Continental Breakfast
9:00 – 10:30 AM
Interagency Enforcement Action: An Inside Look
Even the most veteran enforcement professionals are not always privy to how the federal government works across agencies to collaborate on enforcement actions. This panel will provide a unique first-hand perspective from agency officials across the federal government on how they communicate, collaborate, and implement enforcement actions.
Richard Cleland, Assistant Director, Advertising Practices, Bureau of Consumer Protection, FTC
Jill Furman, Deputy Director, Consumer Protection Branch, DOJ
Beth P. Weinman, Associate Chief Counsel for Enforcement, Food & Drug Division, OGC, FDA
Domenic Veneziano, Director, Division of Import Operations, FDA
Jill Furman, Deputy Director, Consumer Protection Branch, DOJ
Beth P. Weinman, Associate Chief Counsel for Enforcement, Food & Drug Division, OGC, FDA
Domenic Veneziano, Director, Division of Import Operations, FDA
Moderated by Casper Uldriks, Owner, Encore Insight LLC
Networking Break
10:45 AM – 12:15 PM
Criminal and Civil Enforcement: Domestic and International Developments / Slides
In our ever-increasing global atmosphere, more companies need to be concerned with criminal and civil enforcement matters in the domestic and international arenas. This session will touch on the largest criminal and civil concerns, including warning letters, how FDA defines inspections, import detentions, and the sharing of information between civil and felony prosecutions of corporate officers, with specific discussion of the Peanut Corporation of America case.
Daniel Jarcho, Partner, McKenna, Long & Aldridge LLP
Cathy L. Burgess, Partner, Alston & Bird LLP
Eugene Thirolf, Consultant, former Director of Office of Consumer Litigation, DOJ
Anne K. Walsh, Director, Hyman, Phelps & McNamara, PC
Cathy L. Burgess, Partner, Alston & Bird LLP
Eugene Thirolf, Consultant, former Director of Office of Consumer Litigation, DOJ
Anne K. Walsh, Director, Hyman, Phelps & McNamara, PC
Moderated by Gary Messplay, Partner, Hunton & Williams LLP
12:15 – 1:30 PM
Luncheon Address: Second Annual Eric M. Blumberg Memorial Lecture
Luncheon Address: Second Annual Eric M. Blumberg Memorial Lecture
Mark S. Brown, Partner, King & Spalding LLP
Introduction: Tara Boland, Associate Chief Counsel for Litigation, Office of Chief Counsel, FDA
Introduction: Tara Boland, Associate Chief Counsel for Litigation, Office of Chief Counsel, FDA
1:30 – 2:15 PM
Session 1: Clinical Trial Data Integrity / Slides
The ability of FDA to determine if a new test article is safe and effective is primarily dependent on the interpretability of study data obtained at the Investigative Site. Panelists will discuss FDA’s jurisdiction in this area, the effect on data integrity caused by lack of design-reviewed processes and quality systems, data fabrication, and what to watch out for if you are an investigator or sponsor.
Eve Brunts, Partner, Ropes & Gray LLP
Jur Strobos, MD, Of Counsel, Olsson Frank Weeda Terman Matz, PC
Anton-Lewis Usala, MD, President and CEO, CTMG, Inc.
Jur Strobos, MD, Of Counsel, Olsson Frank Weeda Terman Matz, PC
Anton-Lewis Usala, MD, President and CEO, CTMG, Inc.
Session 2: The Business Case for Supplier Quality and the DQSA – Enforcement and Administrative Actions Resulting from Inadequate Oversight and Control of Suppliers / Slides
During this session, panelists will address recent FDA enforcement actions under the DQSA, including upcoming enforcement matters to watch for. Panelists will also discuss due diligence with regards to selecting a supplier, including how to ensure your supplier is in compliance, and what to do if there is a data integrity issue with your supplier and how to aid in remedying this issue.
Jacqueline R. Berman, Associate, Morgan, Lewis & Bockius LLP
Lori Hirsch, Managing Counsel, Merck & Co., Inc.
Roy Sturgeon, President, Lachman Consulting Services, Inc.
Lori Hirsch, Managing Counsel, Merck & Co., Inc.
Roy Sturgeon, President, Lachman Consulting Services, Inc.
Session 3: What Does FDA Consider During a Food Inspection? How will FSMA Change This? / Slides
The Food Safety Modernization Act will affect changes in food inspections. Panelists will address these changes, such as recordkeeping, what gets inspected and how document review will change. New recordkeeping and other requirements specific to the Foreign Supplier Verification Program, sanitary transportation, and produce safety will also be addressed. Panelists will also discuss how FSMA affects the making and implementation of a Hazard Analysis and Critical Control Points system.
Miriam Guggenheim, Partner, Covington & Burling LLP
Elizabeth Fawell, Associate, Hogan Lovells LLP
Lisa Heinzerling, Professor of Law, Georgetown Law
Elizabeth Fawell, Associate, Hogan Lovells LLP
Lisa Heinzerling, Professor of Law, Georgetown Law
Session 1: Drugs and Medical Devices: Recalls and Warning Letters
Panelists will discuss the most significant recent trends in warning letters and recalls for drugs, medical devices, and mobile health. They will also discuss the recent FDA guidance on distinguishing medical device recalls from enhancements, and challenges for achieving compliance.
Jennifer Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP
Jason Brooke, CEO & General Counsel, Vasoptic Medical Inc.
Jeff Gibbs, Director, Hyman, Phelps & McNamara, P.C., Board Member, FDLI
Jason Brooke, CEO & General Counsel, Vasoptic Medical Inc.
Jeff Gibbs, Director, Hyman, Phelps & McNamara, P.C., Board Member, FDLI
Moderated by Judith Meritz, Associate General Counsel, Covidien Ltd.
Session 2: Promotion Enforcement: FDA's Social Media Guidance / Slides
In June 2014, FDA released its Guidance for Industry on use of social media platforms. This panel will discuss the lessons that can be learned from the enforcement actions FDA has taken thus far, and what issues companies may consider regarding how to avoid enforcement for social media corrections and other gray areas. Speakers will also address FDA enforcement actions for products not covered by the Guidance, such as food and dietary supplements.
In June 2014, FDA released its Guidance for Industry on use of social media platforms. This panel will discuss the lessons that can be learned from the enforcement actions FDA has taken thus far, and what issues companies may consider regarding how to avoid enforcement for social media corrections and other gray areas. Speakers will also address FDA enforcement actions for products not covered by the Guidance, such as food and dietary supplements.
Kristi Wolff, Associate, Kelley Drye & Warren LLP
Joy Liu, Partner, Ropes & Gray LLP, Board Member, FDLI
Dale Cooke, President, PhillyCooke Consulting
Joy Liu, Partner, Ropes & Gray LLP, Board Member, FDLI
Dale Cooke, President, PhillyCooke Consulting
Networking Break
3:20 – 4:35 PM
Counterfeiting and Fraud: What Food and Drug Law Stakeholders Need to Know / Slides
Counterfeiting affects every area of food and drug law. Panelists will discuss issues specific to each sector, as well as overarching themes relevant to all. Topics include: tobacco counterfeiting and fraud, how criminal prosecutions for counterfeiting are brought, track-and-trace initiatives for pharmaceuticals, food fraud, how to handle gray market product and diverted product situations, and the Intellectual Property division at the Department of State and how embassies can aid in counterfeiting issues.
Carla Cartwright, Associate Director, Global Regulatory Policy and Intelligence, Johnson & Johnson, Inc.
Damon DuBord, Economic/Commercial Officer, Office of Intellectual Property Enforcement, U.S. Department of State
Martin Hahn, Partner, Hogan Lovells LLP
Owen McKeon, Director, Gibbons P.C.
Martin Hahn, Partner, Hogan Lovells LLP
Owen McKeon, Director, Gibbons P.C.
4:35 PM
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