[Seminar] Overview of E&L Regulatory Compliance and FDA Requirements and Considerations

basic information

【Lecture Overview】 Currently, in the approval application process for pharmaceuticals in Europe and the United States, Extractables and Leachables (E&L) testing is mandatory, and the evaluation and management of compounds that leach from packaging materials and manufacturing supplies into pharmaceuticals is required. In Japan, for pharmaceuticals with a high risk of leaching, particularly injectable drugs, the submission of E&L testing data is also required. In addition to the United States Pharmacopeia (USP) guidelines USP1663 and USP1664, many guidelines have been presented by organizations such as PQRI and BPOG, and the development of international harmonized guidelines, ICHQ3E, is also underway. This course will provide a detailed explanation of the basics of E&L, market trends, and representative guidelines using historical context and specific examples. 【Lecture Topics】 ■Overview of Extractables and Leachables (E&L testing) ■Requirements regarding E&L from the FDA ■Differences in guidelines for manufacturing materials (USP665 vs BPOG) ■Related Q&A

Price information

[Course Fee] 1 person: 37,480 yen (including tax) From 2 people onwards: 32,480 yen (when applying simultaneously from the same company or affiliated company)

Delivery Time

Applications/Examples of results

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