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 Day One

 Day Two

 Day Three

 

Agenda: Day 2
Thursday, Aug. 24, 2006


MORNING

Morning Track 1 - Drug Safety and Risk Management

8:00 a.m.




Welcome and Introduction

Linda Horton, Esq.
Partner, Hogan & Hartson
Former Director of International Policy, FDA
Brussels, Belgium
(Co-Chair)

Geoffrey Levitt, Esq.
Vice President and Chief Counsel
Regulatory and Research, Wyeth Pharmaceuticals
Collegeville, PA
(Co-Chair)
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

8:15 a.m.


Postmarket Assessment of Drug Safety at the FDA

CAPT Paul J. Seligman, MD, MPH
Associate Director for Safety Policy and Communication
Center for Drug Evaluation and Research, FDA
Silver Spring, MD
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

9:00 a.m.


Where is EU Drug Safety Law Headed: Are Controls Tightening?

Linda Horton, Esq.
Partner, Hogan & Hartson
Former Director of International Policy, FDA
Brussels, Belgium

9:45 a.m.




Innovator Drug Development in a Pharmacovigilant Environment

Gregory Page, Ph.D.
FDA Life Sciences Practice Leader
Life Science and Healthcare Regulatory Practice
Deloitte & Touche
Jericho, NY

George Serafin
Senior Manager, Life Science and Healthcare Regulatory Practice
Deloitte & Touche
Parsippany, NJ
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

10:30 a.m.

Break

11:00 a.m.


FDA Oversight of Drug Safety: What Works, What Doesn't

Geoffrey Levitt, Esq.
Vice President and Chief Counsel
Regulatory and Research
Wyeth Pharmaceuticals
Collegeville, PA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

11:45 a.m.


Risk Management Strategy Through the Life Cycle of Pharma and Biotech Products

Stephen Paul Mahinka, Esq.
Partner, Chair, Life Sciences Interdisciplinary Practice
Morgan, Lewis & Bockius LLP
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Gregory T. Parks
Partner, Morgan, Lewis & Bockius, LLP
Philadelphia, PA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

12:30 p.m.

Networking Luncheon in Annenberg Hall

Morning Track 2: Advertising, Promotion and Compliance

8:00 a.m.




Welcome and Introduction

John Kamp, JD, Ph.D.
Executive Director, Coalition for Healthcare Communication
Of Counsel, Wiley Rein & Fielding LLP
Washington, DC
(Co-chair)
No Presentation Provided


Wayne Pines
President, Regulatory Services and Healthcare, APCO Worldwide
Former Associate Commissioner for Public Affairs, FDA
Washington, DC
(Co-chair)
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

8:15 a.m.


Moving from DTC to DTC Squared: Direct-to-Patient Communications in the 21st Century

Peter Pitts
President, Center for Medicines in the Public Interest
Senior Vice President for Global Health Affairs, Manning, Selvage & Lee
Former Associate Commissioner for External Relations, FDA
New York, NY
Presentation Material (Acrobat)

9:00 a.m.


Meeting the Latest FDA and OIG/DOJ Marketing Rules

Wayne Pines
President, Regulatory Services and Healthcare, APCO Worldwide
Former Associate Commissioner for Public Affairs, FDA
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

9:45 a.m.


Pharma Funding, Fraud and the First Amendment: A Critical View of Recent Federal Enforcement Actions

John Kamp, JD, Ph.D.
Executive Director, Coalition for Healthcare Communication
Of Counsel, Wiley Rein & Fielding LLP
Washington, DC
No Presentation Provided


10:30 a.m.

Break

11:00 a.m.


Innovative Models of Compliance Education: The 'Intellinex' Case Study

Jeffrey Lenow, MD, JD, FAAFP
Associate Professor, Department of Family and Community Medicine
Jefferson Medical College of Thomas Jefferson University
EVP, Chief Medical Officer, CardinalHealth
Medford, NJ
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

11:45 a.m.


The Most Important Element to Assure That Your Sales and Marketing Compliance Program Is Working Effectively

Kelly Freeman, Ph.D.
Director, Compliance and Ethics
Eli Lilly and Company
Indianapolis, IN
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

12:30 p.m.

Networking Luncheon in Annenberg Hall

Morning Track 3: Where the FDA and CMS Meet

8:00 a.m.


Welcome and Introduction

Robert Barton
Editorial Director, FDAnews
Falls Church, VA
(Co-chair)

8:15 a.m.


The Role of Medicare National Coverage in the Regulatory Process

Steve E. Phurrough, MD, MPA
Director, Coverage and Analysis Group
Office of Clinical Standards & Quality
Centers for Medicare & Medicaid Services
Baltimore, MD
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

9:00 a.m.


Coordination Between FDA and CMS: Strategic Considerations for Medicare Coverage AND Payment, and the Growing Impact of CMS in the Marketplace

Kirk Dobbins, JD
Of Counsel, Hyman, Phelps & McNamara, P.C.
Former Senior Staff Attorney and Acting Supervisory Attorney for Litigation
Office of the General Counsel, HHS, CMS
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

9:45 a.m.

CMS Data and Price Information Collection: What Are the Implications?

Ann Leopold Kaplan, Esq.
Assistant General Counsel, PhRMA
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

10:30 a.m.

Break

11:00 a.m.


Reckoning with the Growing Impact of CMS on Product Development and Life Cycle Management for the Research-Based Biopharmaceutical Industry

Matthew Van Hook, Esq.
Partner, Engel & Novitt
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

11:45 a.m.

Policy Implications of Greater FDA/CMS Collaboration

Peter Slone, MBA
Vice President, Government Affairs
Medtronic, Inc.
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

12:30 p.m.

Networking Luncheon in Annenberg Hall

Afternoon Track 4: Drug and Device Development and Clinical Trials

2:00 p.m.


Welcome and Introduction

David Ceryak, Esq.
Assistant General Counsel
Eli Lilly and Company
Indianapolis, IN
(Co-chair)

2:15 p.m.


A Cross-functional Perspective of Key Issues Facing New Product Introductions

Claudio Pincus
President, The Quantic Group
Livingston, NJ
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

R. Owen Richards
President, Quantic Regulatory Services
Livingston, NJ

3:00 p.m.


Climbing the Ivory Tower: Special Challenges for Sponsors of Clinical Trials at Academic Sites

Greg Koski, Ph.D., MD
CPI Associate Professor of Anesthesia
Senior Scientist, Institute for Health Policy, Massachusetts General Hospital
Partners Health Care System, Harvard Medical School
Former Director, Office for Human Research Protections
Office of Public Health and Science, Office of the Secretary, HHS
Boston, MA
No Presentation Provided


3:45 p.m.

Break

4:15 p.m.


Risk Management Through Electronic Enforcement

Joseph Vinhais, RAC
Vice President of Regulatory Compliance, Brooks Software
Chelmsford, MA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

5:00 p.m.




Deciphering Section 505(b)(2) and Its Implications for Product Life Cycles and Regulatory Strategies

David Ceryak, Esq.
Associate General Counsel, Eli Lilly and Company
Indianapolis, IN

Jeffrey Chasnow, Esq.
Senior Corporate Counsel, Pfizer
New York, NY

James Czaban, Esq.
Shareholder, Heller Ehrman, LLP
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

5:45 p.m.

Adjournment

Afternoon Track 5: Compliance and FDA Enforcement

2:00 p.m.


Welcome and Introduction

Marc Wilenzick, Esq.
Senior Corporate Counsel, Pfizer
New York, NY
(Co-chair)

2:15 p.m.


Beginning the Next 100 Years of FDA Regulation - There Have Been a Few Changes Since 1906

Martin Browning
President and Co-Founder, EduQuest
Former Special Assistant to the Associate Commissioner for Regulatory Affairs, FDA
Hyattstown, MD
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

3:00 p.m.


The Policy and Regulatory Challenges of Authorized Generics

David Balto, Esq.
Partner, Robins, Kaplan, Miller & Ciresi
Former Policy Director of the Bureau of Competition of the Federal Trade Commission
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

3:45 p.m.

Break

4:00 p.m.






Regulation, Compliance, Culture or All of the Above

Ann Bacon, Esq.
Compliance Counsel
Boehringer Ingelheim Pharmaceuticals, Inc.
Ridgefield, CT

Gary Giampetruzzi, Esq.
Senior Corporate Counsel, Government Investigation Section
Pfizer, Legal Division
New York, NY

Heather Powell, Esq.
Compliance Counsel
Cephalon, Inc.
West Chester, PA

Adam Turteltaub
Corporate Relations Executive, LRN
Los Angeles, CA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

4:45 p.m.




Compliance Panel Discussion: PDUFA and FDA Reform

Daniel Carpenter, Ph.D.
Professor and Director of Graduate Studies
Department of Government, Harvard University
Cambridge, MA
Presentation Material (Acrobat)

Daniel Kracov, Esq.
Partner, Co-Head, Pharmaceutical and Medical Device Practice
Arnold & Porter
Washington, DC

Marc Wilenzick, Esq.
Senior Corporate Counsel, Pfizer
New York, NY
(Moderator)
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

5:45 p.m.


Role of Technology in Commercial Risk Management and Compliance

John McGrory
President and CEO, Edge Dynamics
Redwood City, CA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

6:15 p.m.

Adjournment

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