Our estimated colleagues Carla Landolfi and Giorgina Mangano participated in the 21st edition of the Italian Society of Toxicology (SITOX) National Congress, held in February in Bologna.
Our experts presented a poster during the event, providing approaches to safety evaluations of individual Extractables and Leachables.
In fact, leachables from Container Closure Systems (CCS) can represent a potential safety risk to patients. The ICHQ3E is arriving to define approaches to perform an assessment for this class of impurities. Current regulatory guidelines and industry standards provide general guidance on compound-specific safety assessments but do not provide a comprehensive approach to safety evaluations of Leachables and/or Extractables.
We are looking forward to next year’s edition!