AQbD Symposium - Day 2 - Applying Q14 to Today's Analytical Challenges
AQbD Symposium 2024 (Impact of Q14/Q2 on LC Procedures)
Analytical Quality by Design (AQbD) is a science and risk-based approach to analytical procedure development that “starts with the end in mind”.
The recently adopted quality guidelines Q14 and Q2(R2) leverage AQbD principles. What does that mean for the Pharma LC lab? We are joined by industry thought leaders for an engaging discussion that will encompass strategies and case studies.
Each session will feature a panel of forward thinking leaders on the topic who will present their recent work and participate in a round table discussion.
Learning Objectives
- Understand opportunities and barriers related to the implementation of Q14
- Learn about analytical development strategies for every phase of clinical development
- Explore case studies applying Q14 to today’s analytical challenges
- Engage with pharma industry thought leaders
Session 2: Applying Q14 to Today's Analytical Challenges
- Wednesday, December 4, 2024 | Time: 10:00am ET | 3:00pm GMT | 4:00pm CET
With the introduction of Q14 and Q2(R2), companies started working on applying these guidance to challenging analytical methods. Using appropriate software, the analytical methods are developed and validated. Our panelists will discuss some of these analytical challenges and how to overcome them by implementing Q14 and updating towards Q2(R2) in their procedures and processes.
Presenter: James Sweatman, BSc. (Analytical Investigator, Almac Sciences)
James Sweatman holds a bachelor’s degree in chemistry from the University of Liverpool, UK and a master’s degree in analytical chemistry from the university of Huddersfield, UK and is currently an Analytical Investigator at Almac Sciences in Northern Ireland. With a career in analytical chemistry spanning over 28 years in the environmental and healthcare fields, he is an expert in analytical method development for small molecules with various chromatographic and spectroscopic techniques. Since joining Almac Sciences in 2007, he has led the analytical development and validation support for many small molecule GMP manufacturing campaigns. He previously conducted a trial of the FusionQdB®softwareand is now working to implement this at Almac Sciences.
Presenter: Jerome Pretre, MSc. (Analytical Technical Leader, Almac Sciences)Jerome Pretre holds a master’s degree in biochemistry from the University of Besancon, France and is currently an Analytical Technical Leader at Almac Sciences in Northern Ireland. With a career spanning over 20 years in analytical chemistry, he is an expert in analytical method development for small molecules and peptides with various techniques such as LC, GC, IC or KF.
Since joining Almac Sciences in 2015, he has led the development and validation of several analytical purity methods for peptide drug substances. He previously established a systematic approach for the development of these new purity methods, and he is now working on implementing the Analytical Quality by Design (AQbD) approach using the Fusion QbD® software.
Presenter: Arnaud Delobel Ph.D. (R&D and Innovation Director, Quality Assistance)Arnaud Delobel is the R&D and Innovation Director at Quality Assistance, with expertise in analytical sciences spanning across all types of therapeutic modalities. He is a recognized expert in the 'MAB Working Party' at the European Directorate for the Quality of Medicines (EDQM) in Strasbourg. Additionally, he contributes to academic discourse through lectures at the University of Strasbourg.
Arnaud graduated from ECPM Strasbourg, focusing his PhD on the mass spectrometry of proteins and peptides at the CNRS in Gif-sur-Yvette, France. He then completed a post-doctoral fellowship in Liège, Belgium, centered on proteomics. Joining Quality Assistance in 2006, Arnaud has climbed the ranks, holding various roles before assuming his current position as R&D and Innovation Director in 2016.
In his role, Arnaud oversees internal R&D initiatives aimed at implementing cutting-edge analytical technologies. These technologies are designed to be offered by Quality Assistance to its clientele. He also guides Product Experts in identifying market needs, leveraging insights from Management, Regulatory Affairs, external experts, and comprehensive data analytics. His team works diligently to transform these insights into innovative R&D services.
Presenter: Ilse Hoes, Ph.D. (Manager Informatics Customer Success Team, WGS Europe, Waters Corporation)Ilse Hoes presides over a distinguished team of European consultants at Waters. The consultancy team provides unparalleled global support, specializing in the meticulous analysis and optimization of workflows. They also offer comprehensive training on the Empower Method Validation Manager, ensuring clients achieve excellence in their operations.
Presenter: Arjan Timmerman (Pharma Market Development Manager EMEA, Waters Corporation)Arjan Timmerman is a market development manager at Waters working in EMEA. Prior to joining Waters in 2014 he worked for 17 years as an Analytical Scientist in the Small Molecule Pharmaceutical industry in various Chemical and Pharmaceutical late-stage development labs.
Since 2023 he became QA/QC market development manager for EMEA working in a dedicated team and focuses on Pharmaceutical workflows, AQbD, Impurities, LC Chromatography and Compliance.
