ICH Q3E Guidelines and Its Implications


22nd March 2021 | 10:00 am CET | Jason Creasey, Managing Director at Maven E&L Ltd and Dries Cardoen, Team Leader of Study Directors Inhalation/topical/transdermal products at Nelson Laboratories, LLC |BOOK FREE SEAT FOR THIS WEBINAR

Presented by Jason Creasey, Managing Director at Maven E&L Ltd

 

Jason Creasey is a graduate Analytical Chemist. He setup in 2019 as an independent consultant providing advice on the topic of extractables and leachables (E&L), after working for GSK in the area of extractables and leachables since the mid 1990’s.

Over that time, he has seen demand in this area grow exponentially and Jason has held roles of increasing seniority in relation providing support to extractables and leachables. Before setting up Maven E&L Ltd – a specialist consultancy for all things E&L related, he was the director of a team of analytical chemists who were responsible for GSK’s global R&D support for E&L activities across a wide range of product types and modalities.  He has had the pleasure of commenting on OINDP PQRI guidelines on E&L for GSK and co-authoring a chapter within a book entitled “Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products”.

Since setting up Maven E&L; he continues to present, discuss, and write about E&L. He is a scientific advisor to Extractable and Leachable Safety Information Exchange otherwise known as ELSIE and now is now publishing a regular E&L blog through LinkedIn and his Website (www.MavenEandL.com), mostly recently adding an E&L Forum for exchange of ideas. As well as supporting client projects, among recent E&L activity, he is working and commenting on risk- based approaches to E&L requirements that he hopes will form part of an ICH guidance in the not too distant future.

The challenges of E&L programs on low risk dosage forms

Most research on Extractables and Leachables is done on dosage forms that come with a high risk, like inhalation products, injectables, ophthalmics products, ect. In this webinar, Dries Cardoen will take a closer look at the reasons why low-risk dosage forms do not receive the same amount of attention and why they should. These dosage forms, like oral solutions, transdermal products and dermal products, are categorized by the USP to have a high likelihood of interaction with its packaging materials. The effects of Extractables and Leachables of these formulations are thus to be considered to guarantee the safety of the patients.

First there will be a short overview of the existing regulations concerning Extractables and Leachables in such low-risk dosage forms. The theoretical part is followed by a few hands-on cases. Examples of dermal, transdermal and oral solution products are given. The examples feature the analytical challenges, risk mitigation and toxicological concerns.

Program:

  • E&L programs on lower-risk dosage forms
  • Case studies on transdermal and dermal products
  • Case studies on oral solutions

 

Presented by Dries Cardoen, Team Leader of Study Directors – Inhalation/topical/transdermal products at Nelson Laboratories, LLC

Dries Cardoen received his Ph.D. from the Faculty of Biology at the University of Leuven (Belgium) in 2011. After his academic career as a post-doctoral researcher, he started at Nelson Labs (formerly Toxikon Europe) in 2013 as study director in the Extractables & Leachables Department. From the start, he specialized in E&L projects of inhalation drug products. He is currently leading the team of study directors that is specialized in E&L testing of inhalation drug products and topical and transdermal drug products.

Sponsored by Nelson Labs

Nelson Labs, A Sotera Health company, is the leading, global provider of lab testing and expert consulting services. We perform microbiological and analytical laboratory tests across the medical device, pharmaceutical, and tissue industries. The company is regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex problems. We have over 700 scientists, technicians, and service specialists who diligently perform more than 700 rigorous tests in 13 global laboratory locations.
Based in Belgium, Nelson Labs Europe specializes in providing premium Extractables & Leachables testing services to the pharmaceutical and medical device industries. We also support pharmaceutical companies across the globe in developing worldwide compliance testing strategies to qualify container/closure applications and pharmaceutical production equipment from an Extractables & Leachables perspective.


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