regulatory compliance 

This is the first joined meeting of Microsomes and Drug Oxidations (MDO) and the International Society for the Study of Xenobiotics (ISSX). This meeting will allow participants to choose from a variety of important scientific and educational sessions on drug metabolism, toxicology, pharmacology, molecular biology and related research areas. In addition to an outstanding scientific program, the meeting provides participants access to state-of-the-art exhibits. Charles River will be exhibiting in booth 16 at this event. Stop by our booth to learn more about our full range of drug metabolism and pharmacokinetic studies in support of drug candidate selection or regulatory submission.

The theme of this year’s annual meeting of The Canadian Association for Laboratory Animal Science (CALAS) is “The Heart of the Matter.” In addition, to an exhibit, Charles River is pleased to be participating in this year’s meeting with three posters, a technical presentation and a workshop.

There are several guidance documents which highlight the assays needed to measure immunosuppression, however guidelines for monitoring immunostimulation are lacking. The presentations will focus on assays used to measure immunostimulation for biologics, biosimilars and vaccines. With emphasis on immunogenicity testing, Elispot and cytokine assessments. The presentations will also review how we conduct these safety (toxicity) studies, what makes reproduction and developmental safety (toxicity) study designs unique and different from general safety (toxicity) studies. Why we need to address the issues of male and female fertility, pregnancy, development of offspring for molecules and vaccines that intended for life threatening diseases and when are expected to conduct these evaluations.

This intensive seminar is designed to provide an overview on the basics of LAL test technology with in-depth analysis on the types of test methodology available. In particular, this seminar will focus on problems sometimes encountered in endotoxin testing, including resolving interference issues. The speakers will be available to answer any of your endotoxin testing-related questions.