Opening session: welcome address, F. Horaud; opening address, G.H. Brundtland; the IABS supporting the work of the World Health Organization - the eradication of poliomyelitis, C. Merieux; H.H. Dale and the London Centre for WHO standards - some milestones of the early years, D.R. Bangham. Session 1 Historical perspectives: international biological standardization in historic and contemporary perspective, M.R. Hilleman; standardization of smallpox vaccines and the eradication programme - a WHO perspective, I. Arita; from insulin to amylin - 75 years of biological standardization in endocrinology, S.L. Jeffcoate; biological standards in haemostasis and thrombosis, D.P. Thomas; cell substrates - lessons learned and challenges remaining, J.C. Petricciani. Session 2 New laboratory tools for standardization and control: molecular consistency monitoring of oral poliovirus vaccine and other live viral vaccines, K.M. Chumakov; alternatives to the use of animals for bacterial toxins and antitoxins, D. Sesardic; cytokine and growth factor standardization - the need for research to answer modern issues, A.R. Mire-Sluis; challenges for biological standardization and control in the 21st century, K.C. Zoon. Session 3 Future challenges: the transmissible spongiform encephalography agents - concerns and responses of United States regulatory agencies in maintaining the safety of biologics, D.M. Asher; development and standardization of DNA vaccines, K. Cichutek; control of foot-and-mouth disease by vaccination, F. Brown; standardization and licensing of combination vaccines based on DTP, I. Gust. Session 4 International perspectives: regulation of biologicals in the European Union, G. Vicari; assuring the safety of plasma products - a developing country's perspective (abstract), D. Armstrong; ICH activities on biotech topics, P. Zorzi-Morre; regulation of biologicals in China, H. Zhou; international challenges and public policy issues, N. Morris.