OVERVIEW: THE FTC, ALONG WITH THE FDA, WORK TOGETH 2012 - FDA Guidance Regarding Clinical Trials for Foods, Food Ingredients, and Dietary Supplements - Webinar By GlobalCompliancePanel

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Category online Training,FDA Guidance,Clinical Trials for Foods,Dietary Supplements

Deadline: September 24, 2012 | Date: September 25, 2012

Venue/Country: Wilmington, U.S.A

Updated: 2012-08-29 16:29:31 (GMT+9)

Call For Papers - CFP

Why should you attend: The dietary supplements industry is an active one. The number of products and variety of uses has increased substantially over the past years. Dietary Supplement marketers should make certain that anyone who is involved in the promotion of their products be knowledgeable with the FTC advertising and FDA labeling principles. Two guidance documents will be reviewed in this webinar: "Dietary Supplements: An Advertising Guide For Industry" which is applicable in identifying claims and interpreting ad meaning and "Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act" which is more directly applicable to the FDA recommendations to a product manufacturer have to substantiate a claim under section 403(r) (6) of the Act.

Areas Covered in the Session:

Dietary Supplement Introduction and Overview

The application of FTC law to dietary supplement advertising will be discussed in detail

Identifying the meaning of the claim and interpreting ad 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

Who Will Benefit:

Dietary Supplement Manufacturers

Dietary Supplement Distributors

Sales/Marketing Personnel

Presidents and Executives of Dietary Supplement companies

Managers of Quality Affairs

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, American Society of Clinical Research Professionals and she is a Fellow of the Regulatory Affairs Professionals Society. Dr. Frestedt was named one of the “100 Most Inspiring People in the Life Sciences Industry (by PharmaVOICE, 2011) and one of the top 25 “Industry Leaders/ Women in Business Award (by the Minneapolis/St. Paul Business Journal, 2011).

Webinar By GlobalCompliancePanel

Price List:

Live : $245.00

Corporate live : $495.00

Recorded : $295.00

Phone: 800-447-9407

Fax: 302-288-6884

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