Webinar: Extractables & Leachables for Medicinal Products

Date: Thursday 22 June 2023

Time: 13:00-17:00 BST

Location: Online

Price: €429 + VAT

Topics: Intro to E&L; terminology, regulatory structure; PQRI & USP; best practices & study design; techniques; dealing with unknowns, and more.

'As always, Smithers delivered an organised, professional workshop with interesting and relevant presentations' - Analytical Expert - Novartis

Webinar Agenda

13:00 Introduction to Extractables and Leachables

Origins of E&L
Terminology

14:00 Regulatory - FDA; EMEA etc

Regulatory structure and organisations
PQRI, USP
Dose and risk
Thresholds

14:45 Break

15:00 Chemical characterisation, Extractables, Leachables

A bit about medical devices
Extractables assessments
Leachables and simulations
Toxicological evaluation - where does this fit in?

16:00 Experimental

Techniques: GC-MS/LC-MS/ICP/SH GC-MS etc.
Interpretation of results
Method development/validation
Dealing with unknowns
Toxicology again

Webinar Leaders

'The presenters were well versed with the E&L standards while providing key information to assist with your projects. A great collaboration of experts and information for those who are either a novice or experienced' - Associate Director - Global Regulatory Affairs, Bausch Health