Claudia Vincenzi is the EMA topic lead for the quality of inhalation products and is supporting the revision of the quality and multidisciplinary inhalation guidelines. After graduating in Pharmacy from the University of Trieste in Italy, she obtained a PhD from the University of Bradford for her research on stabilisation of freeze-dried proteins. She started her career in regulatory affairs by joining the MHRA as Pharmaceutical Assessor, where she worked for over 6 years on a broad variety of pharmaceutical products, including inhalation products. She then became Regulatory CMC Director at Mylan Global Respiratory Group. During her three and half years with Mylan, she led the preparation of the Module 3 for INDs, IMPDs, ANDA on different inhalation pharmaceutical forms (DPI, inhalation solutions and suspensions) and reviewed the MAA quality part of partnership projects (pMDIs). Since June 2016, Claudia works in the EMA Quality Office providing scientific peer-review of all quality aspects throughout the life cycle of medicinal products, supporting committees, working parties and related groups as well as guidelines.
EMA Update on Quality Guidelines on Inhalation and Nasal Products