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FDA Guidance Regarding Clinical Trials for Foods, Food Ingredients, and Dietary Supplements  

Date & Time: Course "FDA Guidance Regarding Clinical Trials for Foods, Food Ingredients, and Dietary Supplements" has been pre-approved by RAPS as eligible for up to 1.00 credits towards a participant's RAC recertification upon full completion.

 

  

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Instructor Profile: Tuesday, September 25, 2012

10:00 AM PDT | 01:00 PM EDT

Duration: 60 Minutes

Instructor: Joy Frestedt

Location: Online

Price : $245.00

(for one participant)

Overview: The FTC, along with the FDA, work together to ensure manufacturers and distributors are up to date with the requirements for product labeling and acceptable marketing claims. These two organizations will continue to get more involved in dietary supplement regulation and it is important for manufacturers to comply with the current recommendations. This webinar will review the dietary supplement regulations and provisions. We will discuss the meaning of a claim and the types and quality of evidence that may substantiate a claim. This talk will review two current guidance documents on this topic including "Dietary Supplements: An Advertising Guide For Industry" which is applicable in identifying claims and interpreting ad meaning. Key features of substantiating claims will be presented and a review of other issues relating to dietary supplement advertising will be   provided.

Areas Covered in the Session: l

Dietary Supplement Introduction and Overview

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The application of FTC law to dietary supplement advertising will be discussed in detail Identifying the meaning of the claim and interpreting ad

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Joy Frestedt President and CEO, Frestedt Incorporated

meaning What is the substantiation standard and the factors that determine the amount and type of substantiation for claims What design factors affect the quality of a study Other issues that commonly arise in dietary supplement advertising

Click here to register for this webinar

Joy Frestedt, PhD, CCTI, RAC, FRAPS. Dr. Frestedt is the President and CEO of Frestedt Incorporated, a novel virtual Contract Research Organization network of over 50 experts and highly skilled staff meeting specific needs in regulatory, clinical and quality affairs. Dr. Frestedt has over 30 years of scientific, clinical and regulatory experience in the health care, pharmaceutical and medical device industries especially running clinical trials, conducting laboratory analyses and assisting firms with strategic decisions involving clinical research programs, regulatory strategies and the development of quality systems to compete globally. She has held key positions including vice president of scientific, regulatory and clinical affairs at BridgePoint Medical and Humanetics Corporation as well as key management positions with Johnson and Johnson’s Ortho Biotech, Medtronic, Mayo Clinical Trial Services, AstraZenca Pharmaceuticals and Orphan Medical. Dr. Frestedt holds a B.A. in biology from Knox College and a Ph.D. in pathobiology from the University of Minnesota Medical School and she is a member of the American Society of Clinical Oncologists, American Association of Pharmaceutical Scientists, ...more

Who Will Benefit: Suggest a Topic l

Dietary Supplement Manufacturers Dietary Supplement Distributors

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Sales/Marketing Personnel

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Presidents and Executives of Dietary Supplement companies Managers of Quality Affairs

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FDA Guidance Regarding Clinical Trials for Foods, Food Ingredients, and Dietary Supplements