AQbD Symposium - Day 1 - Regulatory changes in Analytical Development
AQbD or Analytical Quality by Desgin is a new approach to analytical method development that “starts with the end in mind”.
Exploring experimental conditions and using statistical tools to search for a suitable set of conditions until the method is stable and quality goals are met, are the key success factors for this enhanced approach.
Regulators welcome this science and risk-based approach as described in several upcoming guidelines from ICH, USP, and BP.
Using the preferred language of regulators when filing applications for both small and large molecules, synthetic or biological drugs can significantly reduce the time-to-market.
Join us on Monday, November 29th and hear from many experts in the Pharma arena on how to increase your knowledge around the analytical procedure and minimize the risk of OOS results.
Day 1 - Regulatory Changes in Analytical Development
USP and BP Pharmacopeias recently announced new General Chapters and presented joint events on the AQbD approach to analytical development explaining why it is important to start with the end in mind. They are paving the road to ICH Q14 which will be published in January 2022 together with the new Q2(R2). You will also learn how Empower Method Validation Manager (MVM) continues to be the perfect tool for this new validation guideline.
15:05 –15:25 (CET): <1220> Analytical Procedures Life Cycle: A New USP Chapter
Presenter: Horacio Pappa (Senior Director of the General Chapters Department, Global Science division, USP)
Dr. Pappa has been with USP since 2003. He is currently the Senior Director of the General Chapters Department, Global Science division of the USP. He provides scientific leadership to a team of scientific liaisons responsible for the activities of seven different expert committees that cover the majority of the USP General Chapters. Horacio earned his Ph.D. in Pharmaceutical Chemistry from the University of Buenos Aires. He has authored many publications and peer-reviewed articles and is a frequent speaker and instructor on topics related to Chromatography and Validation. Prior to joining USP, he worked in the pharmaceutical industry in QA/QC. Horacio held the position of Assistant Professor of Quality Control in the Faculty of Pharmacy at Buenos Aires University, and Executive Secretary of the Argentine Pharmacopeia in the period 1997-2001. He is a Quality Engineer certified by the American Society for Quality.
15:25 –15:45 (CET): BP Supplementary Chapter: The Application of AQbD to Pharmacopoeial Methods
Presenter: Stephen Maddocks (Analytical Chemist, UKs Medicines and Healthcare products Regulatory Agency (MHRA))
Stephen is an Analytical Chemist currently working as the Operations Manager for the British Pharmacopoeia team at the UKs Medicines and Healthcare products Regulatory Agency (MHRA) where he provides support to the Analytical Quality by Design Working Party of the British Pharmacopoeia. Stephen previously held positions at AstraZeneca in chemical development and Sanofi in Technology transfer, both an as analytical chemist.
15:45 –16:05 (CET): Addressing Validation Requirements within Empower
Presenter: Ilse Hoes (Consultant, Waters)
Ilse Hoes is born in Belgium and obtained in 2001 a PhD in Sciences from the University of Antwerp. Currently she is managing a European team of consultants at Waters. The consultancy team is assisting customers with analyzing and optimizing workflows and Empower Method Validation Manager training.
16:05 –16:30 (CET): Live Q&A with all Panelists
Moderator: Heather Longden (Waters Corporation, Pharmaceutical Regulatory Intelligence)
