Jason Creasey, Maven E&L Ltd - Qepler Summits And Conferences

Jason Creasey

Managing Director
Maven E&L Ltd
Stevenage, United Kingdom
Jason Creasey an Expert Consultant and subject matter expert in E&L (extractable and leachables)

Jason Creasey is a graduate Analytical Chemist. He has recently setup as an independent consultant providing advice in the area of extractables and leachables, 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 relating to the support that GSK has given to extractables and leachables (E&L).

Before setting up Maven E&L Ltd, he was the director of a team of analytical chemists who are responsible for GSK’s global R&D support for E&L activities across a wide range of product types and modalities. This included; biopharmaceutical and small molecules including Inhalation, Parenteral and Cell & Gene Therapy use. He has had the pleasure of commenting on PQRI guidelines on E&L for GSK, the E&L section in EMEA guidelines on inhalation and nasal products and co-authoring a chapter within a book entitled “Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products”.

Jason has been a member of several external groups concerned with the development of best practice guides for extractable and leachables issues these include; the IPAC-RS material working group, BPOG and continues as a scientific advisor to Extractable and Leachable Safety Information Exchange otherwise known as ELSIE.

Currently he is working and commenting on risk- based approaches to E&L requirements, which he hopes will form part of an ICH guidance in the not too distant future.

Related Sessions:

Extractables & Leachables
Summit 2019

Get the latest updates in regulation, analytical testing, risk & safety assessment, biocompatibility.
  • 15 Oct 2019
  • Berlin, DE
  • Pharma
Day 2: Wednesday, 16 October 2019
CASE STUDY: Risk Based approaches to Extractable and Leachable Study design.
  • Factors affecting Dose Form risk of leachables
  • A structured approach to assessment of leachable risk
  • Linking risk to extractable or leachable studies
  • How extractable and /or leachable studies reduce project risk
View Details

2nd Annual Extractables &
Leachables Summit 2020

Get the latest updates in regulation, analytical testing, risk & safety assessment, biocompatibility.
  • 22 Oct 2020
  • Virtual,
  • Pharma
Day 1: Thursday, 22 October 2020
CASE STUDY: Top 5 Topics for inclusion in a future ICH document on Extractables and Leachables.
  • Definitions and Glossary of Key Terms
  • Key Risk Factors which drive leachables in Drug Products
  • Principles of Study Design for Extractable Studies & Leachable Studies
  • Agreed Process for Safety Risk Assessment of Leachables
View Details

3rd Annual Extractables &
Leachables Summit 2023

Get the latest updates in regulation, analytical testing, risk & safety assessment, biocompatibility.
  • 11 Oct 2023
  • Virtual,
  • Pharma
Day 1: Wednesday, 11 October 2023
CASE STUDY: To Be Announced
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3rd Annual Genotoxic Impurities
in Pharmaceuticals Summit 2023

Genotoxic Impurities in Pharmaceuticals strategies & new methodologies: analysis, in silico & regulations.
  • 09 Mar 2023
  • Virtual,
  • Pharma
Day 2: Friday, 10 March 2023
CASE STUDY: Optimisation of Nitrosamine analysis in pharmaceutical elastomers
  • A brief history of Nitrosamine detection in pharmaceutical elastomers
  • Example methods of analysis for Nitrosamines (Choice of detector, chromatography & Sample Preparation)
  • Example of a development process & potential pitfalls
  • Example validation results from an optimised method
View Details