When

Monday September 15, 2014 from 9:00 AM to 4:00 PM EDT
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Where

Life Sciences Building (Busch Campus) 
145 Bevier Rd
Suite 101
Piscataway, NJ 08854
 

 
Driving Directions 

Contact

Louli Kourkounakis 
NJ Center for Biomaterials 
732-445-0488 x40001 
cbmfrontdesk@dls.rutgers.edu 

Agenda

9:00am - 10:30am   
• Cosmetic vs. physiological
• FDA requirement for “substantial evidence”
• Translation of data into fair claims
• The stratum corneum structure
• Structural changes
10:30am - 10:45am           Break
10:15am - 12:00pm          The function premise - translation of data into claims:
• In vitro studies:
• Enzymatic studies                    • Cell cultures
• Genomics and proteomics       • Ex vivo studies
• Skin penetration                      • Skin metabolism
• Identifying site of activity         • Stability                        • The therapeutic index concept
12:00pm - 1:00pm -            Lunch
1:00pm - 2:30pm
“Advertising Self-Regulation - A Review of Cosmetics Claims” by guest speaker Annie Ugurlayan, Senior Staff Attorney at the National Advertising Division
2:30pm - 2:45pm                Break
2:45pm - 4:00pm                Clinical study design:
• Panel size and statistical significance
• Validity of pilot runs
• Subjective vs. quantitative evaluation
• Consumer feedback and questionnaire
• Activity of raw materials vs. finished formulation
• Duration of activity
• Ethical and scientific consideration
• Review and summary

 

Are You Ready to Comply with the New EU Draft Regulations for Claims Testing?
Are You Familiar with Advertising Self-Regulation?

The EU Commission issued a draft guideline for claims substantiation in July of 2013. The FDA and the FTC are carefully watching cosmetic products for non-substantiated misleading claims. Ethical issues are raised by misleading claims as the product will not deliver the promised results. With the skin care industry striving to produce safer products, it should also improve its testing methods to better evaluate products activity on the skin and to clearly and accurately communicate the results in product claims. Common criteria for justification of claims are a challenging aspect in product development since they need to be customized for the purpose of use and nature of the product developed. This course is tailored to provide key aspects in the establishment of best practices to be applied in experimental design and tie it into the regulatory framework rationale.

COURSE DIRECTOR
  Nava Dayan, PhD, is founder and president of a skin science and research consultancy serving the pharmaceutical, cosmetic, and personal care industries. Dr. Dayan’s 24 years of experience in the greater skin care segment, have yielded more than 150 publication credits in numerous industry-respected journals four books, as well as an In-Cosmetics Gold Award for innovation and commensurate recognition from the NYSCC and the CRS for excellence. Dayan holds a PhD in pharmaceutics from the Hebrew University in Jerusalem and is the bearer of several patent applications for original work in skin actives and delivery systems. Dr. Dayan services focus on innovation, bridging technology to industry, identifying paths in product development, efficacy claims, safety assessment, skin absorption, increased efficacy and strategies to attenuate adverse effects.

GUEST SPEAKER
Annie Ugurlayan is a Senior Staff Attorney at the National Advertising Division. Since 2003, she has handled over 150 cases, particularly in the areas of cosmetics, food and oral care products, and has successfully argued appeals before the National Advertising Review Board. Annie is also a frequent lecturer at conferences nationwide and abroad.    Annie is actively involved in various
bar associations (Member, New York State Bar Association’s House of Delegates; Member, Information Technology Law Committee - 2012; Former Chair, Consumer Affairs Committee of the New York City Bar Association - 2009-12; Member, Consumer Protection Committee, American Bar Association’s Antitrust Section). She is also a member of the Board of Directors of the New York Women’s Bar Association Foundation. She is fluent in French and Armenian and proficient in Romanian. Annie is a graduate of Hamilton College (B.A., magna cum laude - French and World Politics) and Hofstra University School of Law.