Preparing to navigate European regulatory requirements for gene therapy process validation
Cell & Gene Therapy Insights 2019; 5(4), 471-475.
10.18609/cgti.2019.052
Published: 16 May 2019
Interview
Sol Ruiz
Sol Ruiz
Sol Ruiz is Head of Biologics, Biotechnology and Advanced Therapies at the Spanish Medicines Agency. She has a PhD in Biology (Immunology). She is the chair of the BWP (Biologics Working Party) at the EMA (European Medicines Agency) since March 2014. She is also a member of the CAT (Committee for Advanced Therapies) and a co-opted member of the CHMP (Committee for Human Medicinal Products) since 2007. She also participates in several working groups related to biologics and advanced therapies both at the EMA and at the European Pharmacopoeia.