Extractables & Leachables Analysis
Bratislava, Slovakia, March 10, 2026
TL;DR
Since its inception, extractables and leachables (E&L) has expanded across dosage forms, with increasing regulatory expectations. Analytical challenges in detection, identification, and quantification can cause costly delays. Despite a draft ICH guideline, E&L remains complex. This course builds core E&L understanding to navigate risks successfully.
About the Event
Since its inception the topic of extractables and leachables has grown continuously. It has expanded into different dose forms and heighted regulatory expectations. Analytical requirements still remain a challenge to effectively detect, identify and quantify, and this area if not addressed correctly can add costly delays to the development of new and existing medicines. We now finally have a draft ICH guideline, but E&L is still a complex area to navigate successfully.
The key to successfully negotiating its potential pitfalls is an understanding of E&L core concepts and requirements. This course sets out to provides that detail.
Organization
Extractables & Leachables Analysis is organized by Fleming
Date and Location
The course will take place in Bratislava, Slovakia on March 10, 2026.
Attendance to the this course is Online.
For more information, you can click here to access to the event website.