
|
|
PRESS RELEASE:
2007 FDA Regulatory and Compliance Symposium at Harvard Features Innovative Compliance Strategies Track
- Classes Held in Harvard University's Annenberg Hall, Sanders Theatre and Faculty Club, Cambridge, MA
- August 22 - 24, 2007
- Symposium Hotel: The Charles Hotel, Cambridge, MA
- www.FDASymposium.com
|
PRESS RELEASE
Phone: 800-684-4549
Email: registration@hcconferences.com
Website: www.FDASymposium.com
CAMBRIDGE, MA USA -- PHARMA UPDATE NEWS SERVICE -- JULY 5, 2007: The Third FDA Regulatory and Compliance Symposium, www.FDASymposium.com, August 22 - 24, 2007, in Cambridge, MA announced today that it will feature an Innovative Compliance Strategies Track.
THE VENUES AT HARVARD
|

Classes Held: Harvard University's Annenberg Hall, Lowell Hall, Science Center and the Harvard Faculty Club
Symposium Hotel: The Charles Hotel
|
INNOVATIVE COMPLIANCE STRATEGIES TRACK
|
1:45 p.m. |
Drug Safety Labeling - A Legal Perspective: FDA Authority, Recent Initiatives and Legislative Proposals by Dave Ceryak, Esq., Assistant General Counsel, Eli Lilly and Company, Indianapolis, IN
|
2:30 p.m. |
Proactively Managing International and Foreign Corrupt Practices Act Compliance Risks by Gary Giampetruzzi, Esq., Senior Corporate Counsel, Deputy Compliance Officer, International Investigations and Programs, Pfizer, New York, NY and Keith Korenchuk, JD, MPH, Of Counsel, Covington & Burling, Washington, DC
|
4:30 p.m. |
Really Trained or "Reportedly Trained?" What FDA Warning Letters Say About the Effectiveness of Corporate Training Programs and How to Develop Training Programs Employees Want to Attend by Kristina Spitler, Training Manager, Almac Clinical Services, Durham, NC
|
5:15 p.m. |
Adjournment and Networking Reception
|
|
KEYNOTE SPEAKERS
|
Jerry Avorn, MD
Professor of Medicine, Harvard Medical School, Chief, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Author, Powerful Medicines and The Benefits, Risks, and Costs of Prescription Drugs, Boston, MA
|
|
Lester Crawford, DVM, PhD
Senior Counsel, Policy Directions, Inc., Former Commissioner, FDA, Washington, DC
|
|
Scott Gottlieb, MD
Resident Fellow, American Enterprise Institute, Former Commissioner for Medical and Scientific Affairs, FDA, Washington, DC
|
|
Sonali Gunawardhana, JD
Regulatory Counsel, Center for Devices and Radiological Health, FDA, Rockville, MD
|
|
Joseph Mahady
President, Global Business, Wyeth Pharmaceuticals, Collegeville, PA
|
|
Daniel Meron, Esq.
General Counsel, Department of Health and Human Services, Former Principal Deputy Assistant Attorney General, Civil Division, United States Department of Justice, Washington, DC
|
|
Jon F. Merz, MBA, JD, PhD
Associate Professor, Associate Chair for Faculty Affairs, Department of Medical Ethics, University of Pennsylvania School of Medicine, Philadelphia, PA
|
|
Arthur Miller, Esq.
Bruce Bromley Professor of Law, Harvard Law School, Cambridge, MA
|
|
|
|
Wayne Pines
President, FDA Alliance, President, Regulatory Services and Healthcare, APCO Worldwide, Former Associate Commissioner for Public Affairs, FDA, Washington, DC
|
|
Lucy Rose, MBA
President, Lucy Rose and Associates, LLC; Former Director of the Office of Training and Communications and DDMAC, CDER, FDA
|
|
David Rothman, PhD
Bernard Schoenberg Professor of Social Medicine, Director of the Center for the Study of Society and Medicine, Columbia College of Physicians and Surgeons, Professor of History, Columbia University, New York, NY
|
|
James G. Sheehan, Esq.
New York State Medicaid, Inspector General, Former Associate United States Attorney, U.S. Attorney's Office for the Eastern District of Pennsylvania, Albany, NY
|
|
Tom Stossel, MD
Department of Medicine, Harvard Medical School, Co-Director, Division of Hematology, Brigham and Women's Hospital, Boston, MA
|
|
Daniel Troy, Esq.
Partner, Sidley Austin Brown & Wood, Former Chief Counsel, Office of the General Counsel, FDA, Washington, DC
|
|
Marc Wilenzick, Esq.
Assistant General Counsel, Pfizer, New York, NY
|
|
Helen Winkle
Director, Office of Pharmaceutical Science, Center for Drug Evaluation and Research, FDA
|
|
Susan Wood, PhD
Research Professor, School of Public Health and Health Services, George Washington University, Former Assistant Commissioner for Women's Health, and Director of the Office of Women's Health, FDA, Washington, DC
|
|
|
|
FEATURED SESSIONS
|
Overview of the FDA's Regulatory Compliance Agenda
- FDA: The Need for a 21st Century Budget
- Pursuing Better Drug Regulation Amidst Criticism from Congress
- How FDA can Improve the Quality of its Drug Reviews and Post-Marketing Surveillance, and Why it Must
- Reflections of a Former FDA Chief Counsel: Creative Compliance Strategies
- International Pharmaceutical Regulation and Compliance: Comparisons and Contrasts
- The Role of the Department of Justice in Prosecuting Violations of FDA Regulations
- Industry Collaboration and Interactions With Health Professionals - Can Conflicts of Interest Be Properly Managed?
- Enhancing Post-Marketing Surveillance: Lessons from the Veterans Health Administration
- Update and Impact of Drug Safety Legislation from the 110th Congress
- International Initiatives on Drug Safety
- Risk Management, Risk Communication, and Drug Safety: The U.S. Experience
- Auditing Procedures For Clinical Safety and Pharmacovigilance: Enhanced Compliance, Quality and Public Health
- Pharmacovigilance in the Post-marketing Setting: Results from the RADAR Project
- Analysis of Drug Safety and Consumer Marketing
- Pharmaceutical Advertising and Promotion: Is This Any Way to Run the Railroad?
- The Role of Consumer Protection Law for Prescription Drug Advertising
- FDA: Advancing the Public Health or Being Led by Political Whims?
- The New DTCA Landscape: A Rose by Any Other Name, or Lipstick on a Pig?
- Meeting the Goals of the FDA's QbD Initiative: Risk Management and Pharmaceutical Development
- Going Pro: The Rise of Professionalism in Clinical Research
- FDA Compliance Enforcement Actions: What You Need to Know for Clinical Device Trials
- Seeds of Confusion: Understanding FDA's regulation of Botanical Drugs Versus Dietary Supplements
- Compliance Considerations in Product Development
- Follow-On Biologics: The New Regulatory Frontier
- The Policy and Regulatory Challenges of Authorized Generics
- Forecast for the Generic Pharmaceutical Industry and Their Impact on Brand Manufacturers
- Patent Challenges Post the Medicare Modernization Act
- Drug Safety Labeling - A Legal Perspective: FDA Authority, Recent Initiatives and Legislative Proposals
- Proactively Managing International and Foreign Corrupt Practices Act Compliance Risks
- Really Trained or "Reportedly Trained?" What FDA Warning Letters Say About the Effectiveness of Corporate Training Programs
- DDMAC and Compliance 101: A Primer
- Risk Avoidance Writing: Secrets for Avoiding Liability and Creating Accurate, Powerful Documents in FDA-Regulated Industries
|
FEATURED FACULTY
|
David Balto, Esq.
Private Practice; Former Policy Director of the Bureau of Competition of the Federal Trade Commission, Washington, DC
Charles Bennett, MD, PhD
Professor of Medicine, Northwestern Medical School, Chicago, IL
Richard J. Berman, Esq.
Partner, Arent Fox LLP, Washington, DC
Robert Campbell, JD, MPH, PhD
Health Services Researcher, VISN 8 Patient Safety Center, Tampa, FL
Dave Ceryak, Esq.
Assistant General Counsel, Eli Lilly and Company, Indianapolis, IN
Cathryn Clary, MD, MBA
Vice President, External Medical Affairs, Pfizer, New York, NY
Fran Cunningham, PharmD
Director, VHA Medication Safety Center, Chicago, IL
Kelly Freeman, PhD, MSc
Director, US Affiliate, Compliance and Ethics, Eli Lilly and Company, Indianapolis, IN
Dustin French, PhD
Health Economist, VISN 8 Patient Safety Center, Tampa, FL
Arnold Friede, JD
Senior Corporate Counsel, Pfizer; Former Associate Chief Counsel, FDA, New York, NY
John (Jack) Garvey
Vice President, Compliance & Quality Management, THE WEINBERG GROUP, Princeton, NJ
Gary Giampetruzzi, Esq.
Senior Corporate Counsel, Deputy Compliance Officer, International Investigations and Programs, Pfizer, New York, NY
Stephen A. Goldman, MD, FAPM, DFAPA
Managing Member, Stephen A. Goldman Consulting Services, Former Medical Director, MedWatch, FDA, Morris Plains, NJ
Linda Horton, JD
Partner, Hogan & Hartson; Former Director of International Policy and Deputy Chief Counsel for Regulations, FDA, Brussels, Belgium and Washington, DC
John Kamp, JD, PhD
Executive Director, Coalition for Healthcare Communication; Of Counsel, Wiley Rein, Washington, DC |
|
Anjali Kataria
Co-Founder, FDA-Conformia CRADA Study, Principal Investigator, Sunnyvale, CA
Keith Korenchuk, JD, MPH
Of Counsel, Covington & Burling, Washington, DC
Greg Koski, MD, PhD, 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
Daniel Kracov, JD
Partner, Co-Head, Pharmaceutical and Medical Device Practice, Arnold & Porter, Washington, DC
Michael Labson, JD
Partner, Covington & Burling, Washington, DC
Geoff Levitt, Esq.
Vice President and Chief Counsel, Regulatory and Research, Wyeth Pharmaceuticals, Collegeville, PA
Douglas Long, MBA
Vice President, Industry Relations, IMS Health, Totowa, NJ
Claudio Pincus
President, The Quantic Group, Livingston, NJ
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
R. Owen Richards
President, Quantic Regulatory Services, LLC, Livingston, NJ
Linda Rivero
President, Voice of Persuasion, Alexandria, VA
Nancy Singer
President of Compliance-Alliance; Former Prosecutor, U.S. Department of Justice, Washington, DC
Thomas Sobol, Esq.
Managing Partner, Hagens Berman Sobol Shapiro, Cambridge, MA
Kristina Spitler
Training Manager, Almac Clinical Services, Durham, NC
Alex Sugerman-Brozan
Director, Prescription Access Litigation (PAL) Project, Boston, MA
Ivan Wasserman
Partner, Manatt, Phelps & Phillips, LLP, Washington, DC
|
|
EXHIBIT & SPONSORSHIP INFORMATION
|
Andrew McSherry
300 N. Washington St., Suite 200
Falls Church, VA 22046
Phone: (703) 538-7643
Fax: (703) 538-7007
E-mail: amcsherry@fdanews.com
|
Joni Lipson
100 North 20th Street, 4th Floor
Philadelphia, PA 19103
Phone: (800) 546-3750
Fax: (215) 545-8107
E-mail: joni.lipson@rmpinc.com
|
|
|
|