Belen Gracia, MSc

Belén Gracia joined Parexel in 2022 as Principal Consultant, Non-clinical SME, bringing more than 30 years of regulatory experience. She served at the Spanish Medicines Agency (AEMPS) as Head of Non-clinical Unit for more than 20 years with regulatory interactions with EMA, FDA, Health Canada, MHRA, BfArM and other HAs. She was Spanish delegate member of CHMP’s Safety Working Party (SWP) at the European Medicines Agency for more than 25 years. Her areas of expertise include activities with small molecules, monoclonal antibodies, biosimilars, fusion proteins and other protein products, vaccines, drug device combinations and advanced therapy including gene therapies, somatic cell therapies and tissue-engineered product (TEP) medicinal products. She has expertise in strategic and technical advice to progress non-clinical development covering all phases of development. Broad experience in providing advice and support on non-clinical package to gain entry to FIH trials.