Advanced CMC MasterClass - US edition

With over 22 years of experience in the pharmaceutical industry, Sophie has a strong experience in the CMC Regulatory field. She gained her Masters degree in analytical chemistry from Manchester University and her Chemical Engineer degree from Montpellier School of Chemistry. She went on to work in pharmaceutical development and post-marketing CMC regulatory compliance in companies such as Bayer, PregLem and Laboratoires Galderma. She gained a strong experience in the worldwide regulatory environment for the development, manufacture and control of the medicines.

Since 2015, she runs her own consultancy, delivering advice in pharmaceutical development strategies and providing support in writing INDs and IMPDs, CTD Module 3 and QOS, preparing variations and answering questions from health authorities. Her experience covers a wide range of products (small molecules and biologics) and pharmaceutical forms.

Sophie also delivers training courses on European regulations for pharmaceuticals, writing of the Module 3, how to achieve global regulatory compliance, managing transfers of manufacturing sites and preparing variations for the ASEAN region.