Events

March 6, 2014

Health Law Grand Rounds
Analyzing the Existing FDA Regulatory Framework for New Products: A case study focusing on Probiotics

Speaker: Professor Diane Hoffmann, University of Maryland Carey School of Law, Director, Law and Health Care Program
Time: 12:45pm
Location: Wynne Courtroom (Room 100),Inlow Hall, 530 W. New York Street, Indianapolis, IN
Contact: Hall Center for Law and Health at centerlh@iupui.edu

The Hall Center for Law and Health presents Health Law Grand Rounds with Professor Diane Hoffmann, University of Maryland Carey School of Law, Director, Law and Health Care Program

Analyzing the Existing FDA Regulatory Framework for New Products: A case study focusing on Probiotics
 
Summary of Content:

  • Responding to an NIH Request for Proposals
  • A methodology for analyzing a regulatory framework
  • An overview of probiotics
  • A description of the current FDA regulatory framework
  • Recommendations for adjusting the framework

Diane HoffmanDiane E. Hoffmann, J.D. M.S., is Professor of Law and Director of the Law & Health Care Program at the University of Maryland School of Law.  From 1999 – 2012, she served as Associate Dean of the law school. She received her law degree from Harvard Law School and her Master's degree from Harvard School of Public Health.  She has taught Torts, Law and Medicine, Health Care Law, Legal Problems of the Elderly, Critical Issues in Health Care, Research with Human Subjects, Health Care for the Poor, Legal and Policy Issues in End of Life Care, Conflict Resolution in Health Care, Comparative Health Law, Analytical Methods for Lawyers, and the Health Law Practice Workshop.  She was a primary author of Maryland’s Health Care Decisions Act dealing with medical decision-making for individuals lacking capacity.  She has served as a member of a number of ethics committees including those at University of Maryland Medical Systems, the National Institutes of Health, and the Baltimore VA Medical Center. She also served as a member of the Ethics Commission for the American Association of Homes and Services for the Aging and for the National Hospice and Palliative Care Organization.  She is the founder and director of the Maryland Healthcare Ethics Committee Network.  From June 1994 - May 1995, Hoffmann was the Acting Staff Director of the Senate Subcommittee on Aging reporting to U.S. Senator Barbara Mikulski.  From 1997 - 2004, she was a Mayday Scholar focusing much of her research and scholarship on legal obstacles to the treatment of pain.  She has served on the boards of a number of professional and academic organizations.  In 2011 and 2012 she served as President of the Board of Directors of the American Society of Law, Medicine and Ethics and continues to serve as a member of the Board. Hoffmann has published numerous articles on health law and policy issues in legal journals as well as scientific and medical journals including Science, JAMA, the NEJM and Annals of Internal Medicine.   Her most recent research on the regulation of probiotics is based on an NIH grant she received in 2009. Other recent scholarship includes articles on health claim regulation, telemedicine, medical marijuana and the law, end of life care as a public health issue, the criminal prosecution of physicians for the prescribing of opioids, use of genetic tests in the courtroom, and models for building public health law capacity at the local level.

Registration is now closed but walk-ins are still welcome.

Parking:

Parking is available for a nominal fee at the campus Gateway Garage, located on the corner of Michigan and California Streets (Address is 525 Blackford Street).

Parking is also available for a nominal fee at the Natatorium Garage two blocks west of the law school.

Special Accommodations:

Individuals with disabilities who need special assistance should call (317) 274-8036 no later than one week prior to the event. Special arrangements can be made to accommodate most needs.



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