Alfredo García Arieta, Ph.D.
Associate Vice President
Regulatory Strategies
About Alfredo
Dr. Alfredo García Arieta is the Associate Vice President of Regulatory Strategies and Biopharmaceutics at Simulations Plus.
Dr. García Arieta spent 27 years serving the Spanish Agency for Medicines and Health Products, where he was Head of Area of Pharmacokinetics and Generic Medicines. He was involved in the development of European guidelines as a member of the Pharmacokinetic Working Party and the Methodology Working Party at the European Medicines Agency (EMA), as well as the drafting groups on the Guideline on Quality and Equivalence of Topical Products and the Guideline on Orally Inhaled Products.
Dr. García Arieta has also worked as a consultant on bioequivalence in the WHO Prequalification of Medicines Team, observer as a WHO representative in the Bioequivalence Working Group for Generics of the International Pharmaceutical Regulators Programme, and served as an EC/EU member of ICH M10 EWG. He is a civil servant of the Body of Pharmacist of the National Health of Spain (2001) on leave and a member of the Expert Advisory Panel on International Pharmacopoeia and Pharmaceutical Preparations (WHO).
Dr. García Arieta holds a Bachelor’s degree in Pharmacy, a Master’s degree in Pharmaceutics and Industrial Pharmacy and a PhD in Pharmaceutical Technology, all from Universidad Complutense, Madrid, Spain. Dr. García Arieta also holds a Master’s degree in Statistics in Health Sciences from the Universidad Autónoma de Barcelona, Spain.
