Dr Lembit Rägo works at the World Health Organization in Geneva as co-ordinator of the Quality Assurance and Safety: Medicines team, a position he has held since 1999. Dr Rägo’s team focuses on seven programmes: International Nonproprietary Names, Quality Assurance, Anticounterfeiting, Safety and Pharmacovigilance, Regulatory Support, Quality Assurance and Safety of Blood Products and Related Biologicals, Medicines Prequalification. In 2001 he initiated, in addition to the unit’s routine work, the WHO Prequalification Programme of Medicines. Prior to joining the WHO, he was Professor of Clinical Pharmacology at Tartu University in Estonia, and the founder and first Director General of the Estonian Drug Regulatory Authority, State Agency of Medicines. Dr Rägo participates in the work of the ICH Steering Committee, ICH Global Cooperation Group (GCG) and Regulatory Forum as an official WHO observer. He is also a Vice-Chairman of the Uppsala Monitoring Centre Board. During 2002 to 2004 he was a member of Council of International Organizations of Medical Sciences (CIOMS) Working Group on Pharmacogenetics (which resulted in a book “Pharmacogenetics. Towards improving treatment with medicines”, CIOMS, 2005). He is also serving as designated technical officer for several professional NGOs in official relations with the WHO (such as CIOMS and IUPHAR). His unit issues regular publications such as WHO Pharmaceutical Newsletter (bimonthly) and WHO Drug Information (a quarterly journal). He is a common speaker at Drug Information Association annual meetings and has written a number of scientific and regulatory affairs-related publications (articles in various journals, book chapters, etc).