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Agenda
 Monday, September 8
Go to agenda for Tuesday, September 9 >
7:30 AM |
Registration and Continental Breakfast |
8:30 AM |
FDLI Welcome and Announcements
Conference Chairman’s Introduction and Overview
Wayne L. Pines, President, Regulatory Services and Healthcare, APCO Worldwide
Enforcement Policy Updates from FDA Centers
Moderator
Wayne Pines
Speakers
CBER: Elenita Y. Ibarra-Pratt, RN, MPH, Branch Chief, Advertising and Promotional Labeling Branch (APLB), Division of Case Management (DCM), Office of Compliance and Biologics Quality (OCBQ)
CDER: Thomas W. Abrams, RPh, MBA, Director, Division of Drug Marketing, Advertising, and Communications (DDMAC), Office of Medical Policy (OMP)
CDRH: Ann L. Simoneau, RPh, JD, MBA, Regulatory Counsel, Promotion and Advertising Policy Staff, Office of Compliance
CVM: Christopher Melluso, DVM, Supervisory Veterinary Medical Officer, Post-Approval Review Team, CVM, FDA |
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Refreshment Break |
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FDA’s Draft Guidance on Dissemination of Reprints
Moderator
Minnie V. Baylor-Henry, JD, Vice President, Global Regulatory Affairs-OTC, Johnson & Johnson/McNeil Consumer Healthcare
Speakers
Paul T. Kim, Partner, Foley Hoag LLP
Jeffrey M. Senger, Deputy Chief Counsel, Office of the Chief Counsel, FDA
Ann M. Witt, Health Counsel, Committee on Oversight and Government Reform, U.S. House of Representatives
FDA’s Initiatives in Communicating Risk Information
Moderator
Wayne Pines
Speaker
Nancy M. Ostrove, PhD, Senior Advisor for Risk Communications, Office of Planning, Office of Policy, Planning and Preparedness, Office of the Commissioner, FDA |
12:15-1:45 PM
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Lunch
The Potential Impact of the Presidential Election on Advertising Regulation
Speaker
(Introduced by Wayne Pines)
Richard M. Cooper, Partner, Williams and Connolly LLP |
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1:45 PM
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Update on Direct-to-Consumer Advertising
Moderator
Kristin I. Davis, JD, Deputy Director, DDMAC, OMP, CDER, FDA
Speakers
Kathryn J. Aikin, PhD, Social Science Analyst, Direct-to-Consumer Review Group, DDMAC, OMP, CDER, FDA
Robert T. Dean, Direct-to-Consumer Review Group I, DDMAC, OMP, CDER, FDA
CAPT Jean R. Makie, MS, RD, Regulatory Review Officer, APLB, DCM, OCBQ, CBER, FDA |
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Refreshment Break |
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Defining Scientific Exchange, Pre-Approval “Promotion”, Substantial Evidence and Fair Balance
Moderator
Alan R. Bennett, Partner, Ropes and Gray LLP
Speakers
Coleen E. Klasmeier, Partner, Life Sciences Practice, Sidley Austin LLP
Daniel A. Kracov, Partner, Chair-FDA and Healthcare Practice, Arnold & Porter LLP
Controversy over Conflict of Interest in Continuing Medical Education (CME) – Will Industry Funding Disappear?
Moderator
John F. Kamp, PhD, Executive Director,
Coalition for Healthcare Communication, and,
Of Counsel, Wiley Rein LLP
Speakers
Pamela L. Mason, FACME, CCMEP, Director, Medical Education Grants, AstraZeneca Pharmaceuticals
Hilary J. Schmidt, PhD, Associate Vice President, Medical Education, Sanofi-Aventis
Jennifer Spear Smith, PhD, FACME, Executive Director, Professional Education Support, Wyeth Pharmaceuticals |
| 5:30 PM |
Adjournment for the Day |
5:30-6:30 PM
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Networking Reception
Brought to you in part by
Lachman Consultant Services, Inc. |
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Tuesday, September 9
Go to agenda for Monday, September 8 >
8:00 AM |
Continental Breakfast |
8:30-10:30 AM
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Concurrent Breakout Sessions
Drugs/Biologics
Moderator
Lucy Rose, Managing Director, Life Sciences Regulatory and Capital Markets, Deloitte & Touche, LLP
Panelists
Kristin Davis, CDER, FDA
Elenita Ibarra-Pratt, RN, MPH, CBER, FDA
Lauren C. Stevens, Vice President and Associate General Counsel, GlaxoSmithKline
Medical Devices
Moderator
Mark E. DuVal, JD, President, DuVal &
Associates, P.A.
Panelists
Ralph F. Hall, Counsel, Baker & Daniels, LLC and Distinguished Visiting Practitioner and Professor, University of Minnesota Law School
Sheila M. Hemeon-Heyer, JD, RAC, Vice President, Global Regulatory Affairs, Boston Scientific Corporation Inc.
Ann Simoneau, CDRH, FDA
Veterinary Medicine
Moderator
Christopher Melluso, CVM, FDA
Panelists
Cathie S. Marshall, DVM, Consumer Safety Officer,Division of Compliance, Office of Surveillance and Compliance, CVM, FDA
M. Elizabeth McKenzie, PhD, Director, U.S. Regulatory Affairs, Pfizer Animal Health
Nadine R. Steinberg, Supervisory Regulatory Counsel, Office of Surveillance and Compliance,
CVM, FDA
Michael T. Van Koevering, PhD, Manager, Regulatory Compliance, Elanco Animal Health |
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Refreshment Break |
10:45
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How to Conduct an Advertising Review
Moderator
Michael A. Misocky, RPh, JD, President, Misocky Consulting Group, LLC
Speaker
Bhavana Desai, Senior Director, Advertising and Promotion Compliance, Allergan, Inc.
Linda Ballai Fischer, Senior Director, Regulatory Affairs, King Pharmaceuticals, Inc.
Update on Off-Label Settlements –
What is the U.S. Department of Justice (DOJ) Concerned About?
Moderator
Mark C. Levy, Partner, Saul Ewing LLP
Speakers
Jeffrey S. Bucholtz, Principal Deputy Assistant Attorney General, Civil Division, U.S. Department of Justice
Mary E. Riordan, Senior Counsel, Administrative and Civil Remedies Branch, Office of Inspector General, U.S. Department of Health and Human Services
Lynn Shapiro Snyder, Senior Member, Epstein Becker & Green, P.C. |
12:30-2:00 PM
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Lunch
Controversies with Conflict of Interest and Education and Marketing: One Company’s View
Speaker
(Introduced by John Kamp)
Cathryn M. Clary, MD, MBA, Vice President, U.S. External Medical Affairs |
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2:00 PM
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The New PhRMA Code
Moderator
Wayne Pines
Speaker
Diane E. Bieri, Senior Vice President and General Counsel, PhRMA |
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Complying with Corporate Integrity Agreements
Moderator
Norman A. Drezin, RPh, JD, President,
Drezin Consultants, LLC
Speakers
Thomas E. Costa, Vice President, U.S. Pharmaceuticals Compliance
Douglas B. Farquhar, Principal, Hyman, Phelps & McNamara, P.C. |
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Refreshment Break |
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Questions and Answers with FDA
Moderator
Wayne Pines
Speakers
CBER: Elenita Ibarra-Pratt
CDER: Thomas Abrams
CDRH: Ann Simoneau
CVM: Christopher Melluso |
4:45 PM |
Closing Remarks and Adjournment
Wayne Pines |
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