|
AGENDA: PRECONFERENCE
Wednesday, September 30, 2009
|
|
7:00 a.m. |
Registration
|
Preconference Symposia (Choose one Preconference only)
|
PRECONFERENCE I: CLINICAL TRIALS
|
|
8:00 a.m. |
Welcome and Introductions
Mark DeWyngaert, PhD
Managing Director, Huron Consulting Group, LLC, New York, NY (Chair)
|
|
8:15 a.m. |
New Trends in Clinical Research: Increased Oversight and Transparency
Elizabeth V. Jobes, Esq.
Chief Compliance Officer, Adolor Corporation; Former Senior Director, Global Compliance Officer, Cephalon, Inc.; Former Assistant District Attorney, Philadelphia District Attorney's Office, Exton, PA
Nikki Reeves, JD, MPA
Partner, FDA & Life Sciences Practice Group, King & Spalding, Washington, DC
Presentation Material (Acrobat)
|
|
9:00 a.m. |
Mitigating the Growing Risk Posed by the FCPA and Global Anti-bribery Regulations
Stuart Altman
Partner, Washington DC, Hogan & Hartson, Washington DC
Presentation Material (Acrobat)
|
|
9:30 a.m. |
Understanding the New Complexities of Clinical Trials from Results Reporting and FMV
to Off-label Promotion and Aggregate Spend
Kathy Tench
Manager, Huron Consulting Group, New York, NY
Mark DeWyngaert, PhD
Managing Director, Huron Consulting Group, LLC, New York, NY
Presentation Material (Acrobat)
|
|
10:15 a.m. |
Break
|
|
10:45 a.m. |
Regulatory Issues Associated with Multi-Regional Trials
Background Materials
Charles B. Cairns, MD, FACEP, FAHA
Professor and Chair, Department of Emergency Medicine, UNC School of Medicine, Chapel Hill, NC
Sara F. Goldkind, MD
Senior Bioethicist, Food and Drug Administration, Rockville, MD
Karen J. Maschke, PhD
Editor, IRB: Ethics and Human Research, The Hastings Institute, New York, NY
Kevin Schulman, MD
Associate Director, Duke Clinical Research Institute; Professor of Medicine, Director, Center for Clinical and Genetic Economics; Vice-chair for Business Affairs, Department of Medicine, School of Medicine, Duke University; Director, Health Sector Management Program, Fuqua School of Business, Durham, NC
Presentation Material (Acrobat)
Marc Wilenzick, Esq.
Assistant General Counsel, Pfizer; Former Assistant Chief Counsel, Food and Drug Administration, New York, NY
Presentation Material (Acrobat)
|
|
12:00 p.m. |
Preconference Adjournment; Lunch on your Own
|
|
PRECONFERENCE II: DANGEROUS DOCUMENTS: FINDING LAND MINES IN YOUR FDA REPORTS AND EMAILS
|
|
8:00 a.m. |
During this interactive session, attendees will learn how prosecutors and plaintiffs' lawyers can take sentences from memos and emails out of context and have them imply inappropriate conduct.
Specifically this session will cover:
- Who can be held criminally liable under the law
- What FDA investigators look for when reviewing documents
- The risks of leaving blanks and using white-out in required records
- How to distinguish between fact and opinion
- The dangers in not monitoring employees emails
- Types of information never to include in documents
- Words that will attract the attention of prosecutors or plaintiffs' lawyers
- Why it is crucial to follow a document retention program
- How to build a program to avoid dangerous documents
Nancy Singer, Esq.
President, Compliance-Alliance, LLC; Former Special Counsel, AdvaMed; Founder, AdvaMed Medical Technology Learning Institute, Arlington, VA
|
|
12:00 p.m. |
Preconference Adjournment; Lunch on your Own
|
AGENDA: DAY I
Opening Plenary Session
Wednesday, September 30, 2009
|
|
1:00 p.m. |
Welcome, Introductions and Opening Comments on FDA's Regulatory Agenda
Peter J. Pitts
President, Center for Medicine in the Public Interest; Director of Global Healthcare, Porter Novelli; Former Associate Commissioner for External Relations, Food and Drug Administration, New York, NY (Co chair)
|
|
1:15 p.m. |
Keynote Address: The FDA's Regulatory Agenda for 2010 and Beyond
Margaret A. Hamburg, MD
Commissioner of Food and Drugs; Food and Drug Administration; Former Commissioner, Department of Health and Mental Hygiene, New York City, Silver Spring, MD
|
|
2:00 p.m. |
FDA's Drug Approvals and Safe Use Initiative: A New Paradigm for Drug Safety
Janet Woodcock, MD
Director, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD
Presentation Material (Acrobat)
|
THE PERSPECTIVE OF FORMER CHIEF COUNSEL
|
|
2:45 p.m. |
Off-Label Promotion: Will FDA's Draft Off-Label Guidance Survive?
Gerald Masoudi, Esq.
Partner, Covington & Burling; Former Chief Counsel, Office of the General Counsel, Food and Drug Administration, Washington, DC
|
|
3:15 p.m. |
Law-shaped Incentives and Criminal Enforcement
Richard Cooper, Esq.
Partner, Williams & Connolly, LLP; Former Chief Counsel, Office of the General Counsel, Food and Drug Administration, Washington, DC
Presentation Material (Acrobat)
|
|
3:45 p.m. |
Break
|
|
4:15 p.m. |
New Directions in Federal Preemption
Sheldon Bradshaw, Esq.
Partner and Co-chair, Food and Drug Practice Group, Hunton & Williams LLP; Former Chief Counsel, Office of the General Counsel, Food and Drug Administration, Washington, DC
Presentation Material (Acrobat)
|
|
4:45 p.m. |
FDA What Lies Ahead?
Nancy L. Buc, Esq.
Partner, Buc & Beardsley, LLC, Former Chief Counsel, Office of the General Counsel, Food and Drug Administration, Washington, DC
Presentation Material (Acrobat)
|
PERSPECTIVE ON THE FUTURE OF THE FDA
|
|
5:45 p.m. |
Perspective on the Future of the FDA
Merrill Goozner
Publisher, Gooznews.com and Heath Tech Review, Author, The $800 Million Pill: The Truth Behind the Cost of New Drugs, Former Director, Integrity in Science Project, Center for Science in the Public Interest, Washington, DC
|
|
6:15 p.m. |
Adjournment and Opening Networking Reception
|
|
|
