Margaux Longuespée | Project Manager Quality
EYLIO
Dr. Margaux Longuespée obtained her PhD of chemistry at the University of Strasbourg (France) in 2016. She then dedicated her activities to the development of mass spectrometric (MS) methods for clinical pharmacology and personlized medicine at the University Hospital of Heidelberg (Germany). With her expertise in therapeutic proteins and antibodies, as well as quality management in clinical laboratories, she now serves as Project Manager Quality at EYLIO. She advises and supports biotech companies throughout the development pipeline: from molecule discovery, preparation of regulatory documentation, and QP services and audits, to packaging and storage of the Investigational Medicinal Product (IMP), through to the completion of clinical trials and beyond.
Appearances:
Festival of Biologics Day 1 @ 17:30
Bridging Clinical Operations and GMP Requirements: A Strategic Imperative for Emerging
Clinical operations are a cornerstone of health product development, yet their success relies on seamless alignment with Good Manufacturing Practice (GMP) requirements—particularly in the management of investigational medicinal products and subcontracted activities. This interface, often underestimated, becomes a pressure point for sponsors lacking in-house pharmaceutical resources How can regulatory and GMP constraints be anticipated as early as the clinical planning phase? What are the best strategies to ensure batch certification, qualification of manufacturing partners, or implementation of an efficient quality management system in the absence of in-house resources? This dual perspective—clinical and pharmaceutical—demonstrates how the early integration of GMP requirements into clinical operations is a key success factor, ensuring regulatory compliance, operational efficiency, and credibility with health authorities.
Created by
Terrapinn is proud to be a member of isla.
Working together to build sustainable events