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Testing for Genotoxicity, Mutagenicity and Carcinogenicity: Compliance with REACH and the 7th Amendment

 
  September 04, 2009  
     
 
The Center for Professional Advancement, 90 Minute Accredited Online Training
November 17, 2009 at 11:00 a.m. - 12:30 p.m. (ET)


Who Should Attend
Professionals in the cosmetic and personal care or related industries that work and specialize in the following disciplines, as well as groups or companies that provide services in skin care in the following fields:

  • Research and Development 
  • Regulatory Affairs 
  • Safety Assessment
  • Product Development 
  • Formulations Development

Description
With the unique position of the cosmetic and personal care industry of animal testing ban and emergence of REACH, this course is designed to present key parties involved, their positions, market leads and sources for information.

Compounds that can change the genetic information of a living cell may lead to mutations. These can result in different type of toxic effects, ranging from cell death to the development of a malignant tumor. While a variety of methodologies are currently in use in the area of regulatory genotoxicity, substantial in vivo testing is still required for the confirmation of genotoxic prediction. For the evaluation of carcinogenicity, the only accepted test by regulatory agencies is the in vivo two year bioassay. Therefore, in 2004, ECVAM initiated several activities related to the validation of alternative methods and applied research.

The core of the course is focused on the understanding of current available methodologies, their scope and limitations, including:

Module 1:
  • Definitions
    – Genotoxicity/Mutagenicity
    – Carcinogenicity
  • Relevance to the industry
  • ECVAM's position
  • ICCVAM's position

Module 2:
  • Testing for Genotoxicity/Mutagenicity:
    – Human Hepatocytes Model
    – COMET assay in 3D skin model
    – BALB/c 3T3 model
    – Chromosomes aberration test

Module 3:
  • Testing for Carcinogenicity
    – The in vivo two year bioassay
    – Cell transformation assay in BALB/c 3T3 and SHE
    – Micronucleus test

Summary and Future Direction
Question and Answer Session

 
 
Organized by: The Center for Professional Advancement
Invited Speakers: Dr. Nava Dayan, Skin Care Research Expert

Dr. Dayan earned her Ph.D. in Pharmaceutics from the Hebrew University in Jerusalem specializing in skin delivery. She is currently an Associate Adjunct Professor in the Ernest Mario School of Pharmacy at Rutgers University., and the R&D Director at Lipo Chemicals Inc. During her 22 years of experience she has specialized in a variety of areas related to skin treatment:

  • The research and understanding of the interaction between topically applied compounds and
    the skin
  • Findings in skin biochemistry and especially the upper layer of the skin- the stratum 
    corneum
  • Delivery of active compounds into and through the skin and the development of delivery 
    systems to facilitate transport, improve bio-availability and reduce toxicity
  • Design and development of topically applied formulations
  • Design of clinical studies to substantiate market claims and to assure safety
  • Academic teaching and lecturing
  • Industrial experience in both development of active compounds, delivery systems and 
    finished formulations
  • Skin absorption studies in vivo and in vitro for safety/ efficacy assessment
  • In vitro methodologies for safety assessment of topically applied compounds

Dr. Dayan has received numerous awards of excellence for various papers she has authored. She is the author and co-author more then 100 publications including book chapters and was granted 7 patents. She is also the editor of the “Skin Aging Hand Book”. Dr. Dayan is a member of the Dermatopharmaceutics Focus Group, and the Abstract Review Committee for the American Association of Pharmaceutical Scientists (AAPS), and the Consumer Products Group of the International Controlled Release Society (CRS). She is serves on the advisory board of the NY Chapter of the Society of Cosmetic Chemists, CAAT at John Hopkins University and Health Beauty America Expo. Dr. Dayan chairs the Annual Cosmeceuticals Summit Symposium. She teaches at Rutgers University and is the Director of a variety of courses at the Center for Professional Advancement.
 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: salbers@cfpa.com
 
   
 
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