Congress has just passed the Dietary Supplement and Nonprescription Drug Consumer Protection
Act of 2006. This legislation requires dietary supplement companies to report to FDA within 15
days serious adverse events for dietary supplements. Understanding details of this law and how to
efficiently and effectively assure you are in compliance will become a top industry priority. This
seminar is designed for executives responsible for operations, quality assurance, marketing, legal & regulatory
and scientific affairs, all of whom will be involved in receiving, assessing and reporting SAERs.
8:00 – 8:30 am
8:30 – 8:45 am
|Welcome and Review of the Day|| Loren Israelsen |
United Natural Products Alliance (UNPA)
8:45 – 9:45 am
AERs for Dietary Supplements:
A Political and Consumer Mandate
| Patricia Knight |
Chief of Staff
Senator Orrin G. Hatch
9:45 – 10:45 am
| Critical Provision Analysis: |
Dietary Supplement and Nonprescription
Drug Consumer Protection Act
| Peter Reinecke |
Senior Advisor, UNPA
President, Reinecke Strategic Solutions
Former Chief of Staff
Senator Tom Harkin
10:45 – 11:00 am
11:00 am – Noon
| Creating, Managing or Outsourcing |
a Corporate AER Surveillance Program
Rick Kingston, PharmD
President, Regulatory & Scientific Affairs
Noon – 1:00 pm
|Lunch: Little America Executive Buffet|
1:00 – 2:00 pm
| Dealing with Health Professionals |
in Assessing AERs and Using Cautions
and Warnings on Dietary Supplements
| Don Brown, N.D. |
President, Natural Product Research
Consultants, Inc., Seattle, WA
2:00 – 3:00 pm
| Herb/Drug Interactions: |
Characterizing Herbal and Dietary
Interactions with Pharmaceuticals
| Francis Brinker, N.D. |
Clinical Assistant Professor, Dept. of Medicine University of Arizona
3:00 – 3:15 pm
|Break: Light Refreshments|
3:15 – 4:15 pm
| Stimulant-Based Dietary Supplements: |
Will this be a Major Source of AERs?
| Christine Haller, M.D. |
Assistant Professor of Medicine
and Laboratory Medicine
University of California at San Francisco
4:15 – 5:00 pm
|Q&A: Speakers Panel / Seminar Summary|
5:30 – 7:00 pm
|Reception for All Attendees and Faculty|
During her work for Rep. Broyhill, Ms. Knight was involved in drafting a range of Public Health Service and health care financing legislation, an interest which carried over when she joined HHS in the fall of 1981 as Special Assistant to the Assistant Secretary of Legislation.
She has also been involved extensively in the appropriations
As health advisor to Senator Hatch, Miss Knight was involved in formulating public laws on a range of healthrelated issues, including children’s health, regulation of foods, drugs and medical devices, and Medicare and Medicaid reimbursement. She was the lead staffer on several important laws Senator Hatch authored, including the Children’s Health Insurance Program (CHIP) and the Dietary Supplement Health and Education Act (DSHEA).
Donald J. Brown, N.D.
Francis Brinker, N.D.
From 1993-1999 he served as a botanical medicine instructor at the Southwest College of Naturopathic Medicine in Tempe, Arizona. For the past eight years Dr. Brinker has been involved as a preceptor and instructor in botanical medicine for the Program in Integrative Medicine at the University of Arizona. He is currently on the faculty as clinical assistant professor in the Department of Medicine, College of Medicine.
Mr. Reinecke has played an active role in the development of federal health care policy for over two decades. His experience includes major staff roles in the establishment of six Institutes and Centers at the National Institutes of Health, including the Office of Dietary Supplements, the Office of Alternative Medicine and the National Center for Complementary and Alternative Medicine. He also played a major role in the establishment of the White House Commission on Complementary and Alternative Medicine Policy and was Senator Harkin’s principal advisor in the enactment and implementation of the Dietary Supplement Health and Education Act. Mr. Reinecke also worked on a range of legislation including Medicare reform, child nutrition, the Americans with Disabilities Act as well as measures to reorient the health care system towards prevention and wellness. He served on the White House Health Care Reform Task Force in 1994.
Prior to joining the Senate, Mr. Reinecke worked as
Rick Kingston, PharmD
Dr. Kingston is President, Regulatory and Scientific Affairs for SafetyCall International, a multidisciplinary medical practice and poison center focused on postmarket surveillance and product
He has 23 years critical care toxicology experience gained from practice in a University affiliated Level One Trauma Center. Dr. Kingston completed his Bachelor of Sciences in Pharmacy degree at the University of New Mexico, his Doctorate in Clinical Pharmacy at the University of Minnesota, and a Post-Doctoral Fellowship in clinical toxicology and pharmacokinetics at St. Paul-Ramsey Medical
Christine Haller, M.D.
She is a past recipient of a K23 clinical research award from the National Center for Complementary and Alternative Medicine at the NIH to study the clinical pharmacology of ephedra and caffeine-containing dietary supplements that were previously used for weight loss and performance enhancement. She has conducted six clinical studies and published numerous papers on ephedra and and is well recognized for her expertise on botanical stimulants. She is also a principal investigator for studies examining the pharmacology of gamma hydroxybutyrate (GHB) in humans. Dr. Haller lectures frequently nationally and internationally on the toxicology and pharmacology of herbal medicines and dietary supplements.
Dr. Haller attended the University of Utah and received a Bachelor of Science degree in Chemical Engineering. She earned a Master of Science degree and an M.D. degree through the U.C. Berkeley/U.C. San Francisco Joint Medical Program. She completed a residency in Clinical Pathology at U.C. San Francisco in 1998, and a post doctoral fellowship in clinical pharmacology and toxicology at the Veteran’s Administration Medical Center in San Francisco in 2000, after which she joined the faculty at UCSF in the Division of Clinical Pharmacology and Experimental Therapeutics. She is board-certified in both Clinical Pathology and Medical Toxicology.
|Click here to download the registration form.|