Webinar on Extractables & Leachabes

Free webinar in cooperation with Analytical Services – “Threshold concepts and best practice recommendations for toxicological assessment”, presented by Dr. Koen Van Deun (European Registered Toxicologist).  Scientifically justified safety thresholds for Leachables & Extractables were developed for Orally Inhaled and Nasal Drug products (OINDPs) and Parenteral and Ophthalmic Drug Products (PODP).  These thresholds allow to do a step-wise analysis and assessment of Leachables & Extractables according to their hazard potential. You will learn:


Regulatory background:


  • US: FDA
  • EC: EMA
  • PQRI: Product Quality Research Institute


Some major toxicolocical endpoints:


  • Genotoxicity and carcinogenicity
  • Sensitization & allergenic potential
  • General toxicity


Tresholds used in safety evaluation:


  • Safety Concern Threshold (SCT)
  • Qualification Threshold (QT)
  • Analytical Evaluation Threshold” (AET)


Hazard evaluation methods:


  • Non-testing possibilities
  • Prediction methods
  • Testing


Join the free webinar at 25th November 2014, from 15:00 – 16:00 p.m. (CET).


For registration purpose, please forward an email with your contact details to: info@2bridge.be