Committee for Human Medicinal Products
Committee for Advanced Therapies (AGEMED)
Sol Ruiz is the head of the Unit of Biotechnology and Advanced Therapies at the Spanish Medicines Agency. She got her PhD in Biology (Immunology) in 1997 after completing a 3-year research project in the Dept. of Biochemistry and Molecular Biology at the University of California Irvine (CA, USA). She has been working in a government lab in the quality control of medicinal products (plasma-derived and biotechnological products). She is the Spanish representative in the BWP (Biologics Working Party) at the EMA (European Medicines Agency) since 1997 and vice-chair of the group since September 2007. She also participates in several working groups related to biotechnological/biological products and advanced therapies both at the EMA and at the European Pharmacopoeia. She has been involved as an assessor in the TSE Certification system at the European Pharmacopoeia since the beginning (2000-present) and she has been the chairperson of Technical Advisory Board of this TSE Certification scheme since then (2001-present).
Regulation of advanced therapy medicinal products ( 2.7MB)
The Committee for Advanced Therapies (CAT) will review the recent Regulation on Advanced Therapies, both the opportunities and challenges it has introduced. The main points of the Regulation will be presented including the new Committee on Advanced Therapies (CAT) at the European Medicines Agency (EMA) and its main activities after the first year of its establishment.