[Seminar] Latest Trends in E&L Testing and Key Points for Practical Response

basic information

【Lecture Overview】 Extractables & Leachables (E&L) have been decided to be adopted as ICH-Q3E, gaining attention in the Japanese pharmaceutical industry. Although there is no harmonized guideline across the three regions, it is already required in pharmaceutical development for applications within Japan, and it will inevitably become a regulatory requirement that must be implemented in the future. This lecture will explain the current trends in guidelines, future regulatory plans, and the actual flow of testing implementation. In the latter half of the lecture, we will detail actual issues raised in overseas applications, stumbling points in conducting E&L tests, and key points to consider when performing E&L tests. 【Lecture Items】 ■ Explanation of E&L guidelines ■ The relationship between "Extractables" and "Leachables" ■ Flow of E&L testing ■ Case discussion ■ Introduction of examples of issues raised in the US ■ Introduction of common failures and misunderstandings ■ Related Q&A ~ Participants from competing companies are kindly requested to refrain from attending. ~

Price information

【Participation Fee】 1 person: 50,000 yen (tax included) From 2 people onwards: 45,000 yen (when applying simultaneously from the same company or related companies) - You can view the archive as many times as you like for 2 weeks starting from 3 business days after the seminar ends. - We also accept applications for archive viewing only.

Delivery Time

Applications/Examples of results

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