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"Improving Supplement Safety through Effective Clinical Trial Design"
Date: Monday, May 7, 2007 3pm Eastern
Time: 2pm EDT
Length: 60 minutes
Safety is being brought to the forefront of the dietary supplement industry whether we like it or not and whether we are ready or not. This Webinar is designed to give you the tools to improve the overall safety profile of your ingredient and product lines by addressing the following topics:
- How to review traditional ingredient data from a safety perspective.
- How to evaluate the quality and meaning behind prior clinical trial and case report data.
- How to design pre-clinical, animal, and human clinical trials which properly evaluate the safety risk of your products.
- The basics of post-marketing surveillance for safety and adverse events: When does an event become a “safety signal”?
Based on their conclusions from a recently completed NIH-sponsored systematic review of the literature on the safety profile of herbs, vitamins, and supplements which affect coagulation and bleeding, Dr. Hardy and Dr. Udani will provide background, real-world examples, and clear and concise recommendations as to the best way to protect your company through logical testing and evaluation models.
Speakers:
 Jay Udani, MD, C.P.I., is the CEO and medical director of Medicus Research, a clinical trial CRO serving the pharmaceutical, nutraceutical and functional foods industries since 2001. Udani is also the medical director of the Integrative Medicine Program at Northridge Hospital and assistant clinical professor at the UCLA/Geffen School of Medicine where he is on faculty at the UCLA Collaborative Centers for Integrative Medicine. Udani is a board certified internist who was the chief resident of internal medicine at Cedars-Sinai Medical Center, was the first fellow in integrative medicine at Cedars Sinai, and was among the first physicians in the country to become a Certified Physician Investigator (C.P.I.) for clinical trials through the American Academy of Pharmaceutical Physicians. He has personally run dozens of clinical trials and published over 30 book chapters and articles in many prestigious medical journals including JAMA. Udani is also the recipient of the AMA National Achievement Award, the Harvard Medical School Pinkney Fellowship in orthopaedic research, and was voted Best Physician Specialist and Best Medical Speaker in Los Angeles by the Daily News.
Mary Hardy, MD, board certified in internal medicine and a specialist in botanical and integrative medicine, has actively combined complementary and alternative therapies with traditional Western medicine for many years. She is associate director of the UCLA Botanical Research Center, funded by the National Institutes of Health. She also serves on the scientific advisory board of the American Botanical Council and the editorial boards of Alternative Medicine Alert, Alternative Therapies in Women’s Health, Evidence-Based Complementary and Alternative Medicine, FACT as well as Phytomedicine. Hardy is recognized as an authority on integrative medicine and natural products by organizations such as the Office of Dietary Supplements, the California Medical Board, the American Medical Association, the American Pharmaceutical Association, CBS, NBC, Discovery Channel and the Los Angeles Times. Contributing to the national development of integrative medicine, she serves as the co-chairperson of the Clinical Practice Committee of the Academic Consortium of Integrative Medicine (an organization of the leading medical schools practicing and teaching in this area). She is co-director of the Integrative Medicine Health and Wellness Program at the Venice Family Clinic, the largest free clinic in the United States. Hardy’s recently completed a book for Reader’s Digest, Best Remedies that focuses on integrative medicine.
Webinar Cost:
$99 until April 11
$129 April 11-18
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