Enabling you to identify and mitigate the intrinsic risk in your operations, supply chains and business processes.
Evaluating how your products and services meet and exceed quality, safety, sustainability and performance standards.
Validating the specifications, value and safety of your raw materials, products and assets.
Date: June 20, 2018 | 1pm EDT / 12pm CDT / 10am PDT
In June 2015, a guideline published by the European Medicines Agency came into force (EMA/CHMP/CVMP/SWP/169430/2012). This guideline outlines requirements and methods for establishing health-based exposure limits for active pharmaceutical ingredients (APIs) related to carryover contamination of one API into another API or drug product. The health-based exposure limit is referred to as the permitted daily exposure (PDE) value, and its derivation requires consideration of toxicology/safety data, pharmacology (efficacy) data, the route(s) of exposure, and other information.
This webinar will provide an overview of numerous points to consider when deriving a PDE value for an API. These include identifying relevant data, selecting a point of departure, and applying appropriate adjustment factors to derive a PDE value, as well as requirements for documenting the overall process and other factors. Attendees of this webinar will have a better understanding of why, how, and when to derive PDE values for APIs.
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