Pharmacovigilantes: Changing Dynamics of the Pharmaceutical Post-Market Arena
November 15, 2007
This talk by Harvard Business School professor Arthur A. Daemmrich explored the complex risk choices faced by patients, physicians, industry, and regulators once drugs are on the market, especially in light of changes in post-market data gathering and analysis since the early 1960s. Based on historical and international comparative perspective on post-market monitoring, Professor Daemmrich discussed current controversies regarding meta-analysis and drug safety.
Putting Patients First: Access to HPV Vaccines for Low- and Middle-Income Populations
September 25, 2007
This lecture by Merck Visiting Scholar Kevin Outterson, Professor of Law at Boston University Law School, examined options for vaccine manufacturers and governments looking to ensure access to vaccines which promise to greatly reduce cervical cancer mortality but which are priced beyond the means of most victims of cervical cancer.
The International Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum
June 6-7, 2007, Brussels, Belgium
Along with the Pharmaceutical Compliance Forum, the Health Care Compliance Certification Program co-sponsored this two-day event to advance international compliance programs. The Congress featured panels of compliance experts from around the world as well as current and former prosecutors from the United States and Europe. The topics covered included codes of conduct, international implementation of hotlines, clinical trial registration and reporting, and emerging issues in Asia and the Pacific, Europe and Latin America, among many others.
Health Care Compliance Certification Program: A Focus on State Compliance Issues
May 11, 2007
This single-day session offered compliance professionals and lawyers insight and information on topics including state regulation of the pharmaceutical and medical device industries, state false claims and whistleblower statutes, pedigree laws, and price disclosure issues.
New Jersey’s Broken Health Care System: Charity Care and the Financial Health of New Jersey’s Hospitals, End-of-Life Care and the Uninsured: A Discussion with Fred M. Jacobs, M.D., J.D. Commissioner, State of New Jersey Department of Health and Senior Services
April 10, 2007
Dr. Jacobs, who was reappointed as Commissioner of the New Jersey Department of Health and Senior Services by Governor Jon S. Corzine in January 2006, after having served as Commissioner under former Governor Richard Codey since December 2004, gave an outstanding presentation to Seton Hall Law School’s students, faculty, members of the Health Law Advisory Board, alumni, and members of the greater healthcare community. His candid remarks were instructional for the students and helpful to the many health law attorneys and New Jersey hospital executives in attendance.
My Genes Made Me Do It: Behavioral Genetics and the Punishment of Crime
March 13, 2007
This well-attended and well-received lecture by Merck Visiting Scholar Paul S. Appelbaum, M.D., the Elizabeth K. Dollard Professor of Psychiatry, Medicine & Law at Columbia University Medical Center, and Director of the Division of Psychiatry, Law, and Ethics, Department of Psychiatry at Columbia University, addressed the criminal justice implications of recent discoveries which suggest that a particular gene, combined with adverse experiences early in life, may predispose persons to engage in criminal behavior.
Health Care Compliance Certification Program
March 5-8 and June 25-28, 2007
In 2007, the Health Care Compliance Certification Program held two four-day compliance training sessions on drug and device compliance and oversight. Providing a comprehensive overview of state, federal and international law governing drugs and devices, the programs covered a broad range of topics including: product development and promotion, Anti-Kickback and Stark laws, and investigations and enforcement. The speakers were prominent experts from industry, law and consulting firms, and government. More than 95 registrants attend the March and June sessions.
Access to Health Care as a Human Right: The Need to Protect the Social and Economic Rights of the World’s Poor
February 28, 2007
This lecture was given by renowned medical anthropologist and physician Paul Farmer. Dr. Farmer is a founding director of Partners in Health, an international charity organization that provides direct healthcare services and undertakes research and advocacy activities on behalf of those who are sick and living in poverty. He is also Presley Professor of Medical Anthropology in the Department of Social Medicine at Harvard University Medical School, attending physician in infectious diseases and associate chief of the Division of Social Medicine and Health Inequalities at Brigham and Women’s Hospital in Boston, and medical director of the Clinique Bon Saveur in Haiti. He is the recipient of the Margaret Mead Award from the American Anthropological Association, the American Medical Association’s Outstanding International Physician (Nathan David) Award, and the Heinz Humanitarian Award. He was also awarded a MacArthur Foundation “genius award” and is the subject of Tracy Kidder’s Mountains Beyond Mountains: The Quest of Dr. Paul Farmer, A Man Who Would Cure the World.
A Delicate Balance: The FDA’s Drug and Device Regulations, Public Health, Intellectual Property, and the Economy
February 16, 2007
This Seton Hall Law Review symposium explored the FDA’s role in determining whether a drug is safe and effective for its intended uses, addressing questions including how well the FDA’s approach protects the public health, whether FDA’s safety and efficacy goals and pharmaceutical companies’ interests in strong patent rights and trade secret protections are in balance, and whether FDA should form partnerships with public and private insurers and others to plan cost-effectiveness studies. The symposium featured a keynote address given by Daniel Meron, General Counsel of the United States Department of Health and Human Services.
Emerging Issues in Healthcare Law
February 6, 2007
This presentation, given by Distinguished Guest Practitioner Michael B. McCulley, Assistant General Counsel at Johnson & Johnson, was warmly received by students planning careers in health law as well as by alumni interested in enhancing their careers. The Distinguished Guest Practitioner Series provides health law students an opportunity to discuss health issues with leading area practitioners.