Several ICH Harmonised Guidelines, including ICH Q3A/B and M7 explain the requirements to evaluate the safety of impurities in drug products and active pharmaceutical ingredients (API). Toxicological assessment of impurities in pharmaceuticals requires consideration of toxicology/safety data, pharmacology (efficacy), in silico tools, routes of exposure and other relevant information. Our webinar will provide an overview of the many points to consider when evaluating impurities, including identifying relevant data, selecting a Point of Departure (PoD), and applying appropriate risk approach. Through this webinar, you will better understand why and how to safety assess impurities in pharmaceuticals.

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