Agenda: Day 2
Thursday, August 25, 2005
|
MORNING
|
Track I: Using a Risk/Benefit Model for cGMP Compliance
|
8:00 a.m. |
Welcome and Introduction
Om Lekhraj Lala
Co-President, Harvard College Health Policy Society
Harvard University
Cambridge, MA
(Co-chair)
Aabed Meer
Co-President, Harvard College Health Policy Society
Managing Editor, Harvard Health Policy Review
Harvard University
Cambridge, MA
(Co-chair)
|
8:15 a.m. |
How Do You Know if You Have a World-Class Quality System?
Michael Kowolenko, Ph.D.
Senior Vice President
Pharmaceutical Operations and Technology
Biogen Idec
Cambridge, MA
|
9:00 a.m. |
Undertanding the FDA's Latest cGMP Guidances: Opportunities and Pitfalls
Claudio Pincus
President, The Quantic Group
Livingston, NJ
R. Owen Richards
President and Managing Director
Quantic Regulatory Services
Livingston, NJ
|
10:00 a.m. |
Best Practices in Internal Compliance Auditing
Larry Gibbons
Corporate Vice President, Global Quality
Baxter Healthcare
Round Lake, IL
Willis Ennis
Director, Quality Assurance/Regulatory Affairs
Cambrex BioScience Walkersville
Walkersville, MD
|
11:00 a.m. |
Break
|
11:30 a.m. |
Sustaining Compliance: How to Implement, Measure, Monitor and Improve Your Systems
for Regulatory Compliance
Robert Rhoades
Vice President
Compliance and Quality Management
THE WEINBERG GROUP
Washington, DC
|
|
Track II: Complying With the FDA's Final Risk Management Guidance
|
8:00 a.m. |
Welcome and Introduction
Robert Barton
Editorial Director, FDAnews
Falls Church, VA
(Co-chair) |
8:15 a.m. |
Overview of the FDA's Final Risk Management Guidance
Mark S. Brown, Esq.
Partner, King & Spalding
Former Associate Chief Counsel for Enforcement
Office of the General Counsel
Food and Drug Administration
Washington, DC
|
9:15 a.m. |
How to Select and Develop Interventions to Minimize Risks
Louis A. Morris, Ph.D.
President, Louis A. Morris & Associates
Member, Drug Safety and Risk Management Advisory Committee
Former Director, Division of Drug Marketing
Advertising and Communications, Food and Drug Administration
Dix Hills, NY
|
10:15 a.m. |
Break
|
10:45 a.m. |
How to Test, Pilot and Evaluate Risk Minimization Tools
Annette Stemhagen, Dr.P.H., F.I.S.P.E.
Vice President, Epidemiology & Risk Management
United BioSource Corporation
Member, Drug Safety and Risk Management Advisory Committee
Food and Drug Administration
Ambler, PA
|
11:45 a.m. |
Corporate Compliance Programs: Tools for Managing Emerging Risks - What Might Hit You Next?
Roger W. Louis, Esq.
Chief Compliance Officer, Genzyme
Cambridge, MA
|
12:30 p.m. |
Networking Luncheon
|
AFTERNOON
|
Track III: Using a Risk/Benefit Model for cGMP Compliance
|
1:30 p.m. |
Welcome and Introduction
Om Lekhraj Lala
Co-President, Harvard College Health Policy Society
Harvard University
Cambridge, MA
(Co-chair)
Aabed Meer
Co-President, Harvard College Health Policy Society
Managing Editor, Harvard Health Policy Review
Harvard University
Cambridge, MA
(Co-chair)
|
1:45 p.m. |
Achieving Compliance and Efficiencies Using an Holistic Approach to Your Quality Management System
Steven R. Cagle
Vice President of Marketing and Product Development
Sparta Systems, Inc.
Holmdell, NJ
|
2:30 p.m. |
Reducing Risks through Executive Management and Quality Systems Awareness
Gordon B. Richman
Vice President
Strategic Compliance Consulting and General Counsel
EduQuest
Hyattstown, MD
|
3:15 p.m. |
Break
|
3:45 p.m. |
Drug Quality and Safety: Comparison of EMEA and FDA Rules
Linda R. Horton, Esq.
Partner, Hogan & Hartson
Former Director, International Policy
Food and Drug Administration
Brussels, Belgium
|
4:30 p.m. |
Development and Deployment of a Risk-Based Compliance Turnaround Strategy
John R. Pinion, II
Vice President Quality, Contract Manufacturing and Collaborations, Genentech
Libertyville, IL
|
5:15 p.m. |
cGMP: Good for Business but Who is Enforcing Who?
Anthony Celeste
Senior Vice President
Kendle/AAC Consulting Group
Former Director, Office of Regional Operations
Food and Drug Administration
Rockville, MD
|
6:00 p.m. |
Adjournment
|
|
Track IV: Managing Risks in Product Marketing and Advertising
|
1:30 p.m. |
Welcome and Introduction
Wayne L. Pines
President, Regulatory Services and Healthcare
APCO Worldwide, Former Deputy Commissioner for Communications
Food and Drug Administration
Washington, DC
(Co-chair)
|
1:35 p.m. |
Managing Off-label Promotion Risks
Una Ortell
Director, Regulatory Affairs
TAP Pharmaceutical Products, Inc.
Lake Forest, IL
L. Stephan Vincze, Esq.
Vice President, Ethics and Compliance Officer
TAP Pharmaceutical Products
Lake Forest, IL
|
2:15 p.m. |
Developing Effective Compliance Training for Pharmaceutical Sales Personnel
Kelly B. Freeman, Ph.D.
Director, Compliance and Ethics for Sales, US Affiliate
Eli Lilly and Company
Indianapolis, IN
|
2:45 p.m. |
Break
|
3:15 p.m. |
Managing Risks in Off-Label Promotion and Continuing Medical Education
Arthur N. Levine
Partner, Arnold & Porter
Former Deputy General Counsel for Litigation
Food and Drug Administration
Washington, DC
|
4:00 p.m. |
Managing "New" Regulatory Challenges From the HHS Inspector General, Department of Justice, and Industry Guidelines
Maureen Doyle-Scharff
Director of Professional Services
Ross Products Division, Abbott Laboratories
Columbus, OH
John F. Kamp, J.D., Ph.D.
Of Counsel, Wiley Rein & Fielding
Executive Director, Coalition for Healthcare Communication
Washington, DC
|
5:15 p.m. |
Meeting Latest FDA and FTC Rules on Advertising
Wayne L. Pines
President, Regulatory Services and Healthcare
APCO Worldwide, Former Deputy Commissioner for Communications
Food and Drug Administration
Washington, DC
|
6:00 p.m. |
Adjournment
|
