A guideline, published in June 2015 by the European Medicines Agency (EMA) explains the requirements to determine the Permitted Daily Exposure (PDE) limit for human health of active pharmaceutical ingredients (API) related to cross-contamination on shared facilities. Furthermore, ECETOC guideline and scientific publications set up methodology to calculate the Occupational Exposure Limit (OEL), corresponding to the concentration of a chemical substance into atmosphere that a worker can inhale without risk during working period. Calculation of these HBEL requires consideration of toxicology/safety data, pharmacology (efficacy), routes of exposure and other relevant information. Our on-demand webinar will provide an overview of the many points to consider when calculating PDE and OEL values, including identifying relevant data, selecting a Point of Departure (PoD), and applying appropriate safety factors. Through this webinar, you will better understand why, how and when to calculate PDE and OEL values for chemical substances.

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