Dr. García Arieta is Head of Pharmacokinetics and Generic Medicines of the Spanish Agency for Medicines and Health Care Products and Consultant for WHO Prequalification of Medicines Programme. He was also member of the Methodology Working Party and the Pharmacokinetics Working Party at the European Medicines Agency as well as the drafting groups on the Guideline on Quality and Equivalence of Topical Products and the Guideline on Orally Inhaled Products before joining Simulations Plus, Inc. for 6 months in 2024 to gain experience in PKPB. He holds a Bachelor’s degree in Pharmacy (1993), a Master’s degree in Pharmaceutics and Industrial Pharmacy (1996) and a PhD in Pharmaceutical Technology (1999), all from Universidad Complutense, Madrid, Spain. Dr. García Arieta also holds a Master’s degree in Statistics in Health Sciences (2001) from Universidad Autónoma de Barcelona, Spain.