B8:    International standardization to share pharmaceutical information : efforts of ICH (International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use)

Professor Mihoko Okada PhD is a professor of the Department of Medical Informatics, Kawasaki University of Medical Welfare. She obtained her BS in Mathematics from Tokyo Women's Christian College, MS in Computer Science from the University of Nebraska-Lincoln, and PhD in Medical Science from Niigata University. She was an associate professor of Statistics at the faculty of General Education, Niigata University from 1984 to 1991. She then became a professor of Medical Information Science at Suzuka University of Medical Science. Her recent research interests include pharmaceutical databases, health statistics and statistical databases, and data modelling in healthcare. She has been a member of the ICH Expert Working Group for electronic standards since 1996.

Robert E Hizer (Bob) is an Information Advisor in Clinical and Regulatory Systems at Eli Lilly and Company. He received his BS in Mathematics from Purdue University and his MS in Industrial Engineering from Purdue University. He has worked with clinical trial data collection, remote data entry, adverse experience reporting systems, clinical data analysis and reporting systems, document management applications, and systems that help track and plan the overall clinical program. He has been involved in worldwide electronic regulatory submissions since 1985. Bob is the PhRMA deputy topic leader to the International Conference on Harmonization (ICH) Electronic Standards Expert Working Group. He is a member of the PhRMA/FDA Electronic Regulatory Submissions Working Group and a member of the PhRMA Electronic Labelling Task Force.

Esteban Gonzalez Juarros is Principal Administrator at the Pharmaceuticals and Cosmetics unit of the European Commission. A mathematician by original academic background, he has complemented his training with studies in Computer Science and Engineering. He is responsible for Community information projects in pharmaceuticals, including the Community telematics extranet in pharmaceuticals (EudraNet), the European System for Authorisation of Medicinal Products (ELS/EMP), the European Reporting System in pharmacovigilance (ERS) and the Commission web site re pharmaceuticals. He is EU topic leader at the ICH Expert Working Group responsible for the definition of electronic standards for the transfer of regulatory information and chairs the European Joint Pharmacovigilance Pilot group.

Karel de Neef MD PhD graduated from Leiden University Medical School in the Netherlands. He trained in Clinical Epidemiology at the Thorax Center of the Erasmus University in Rotterdam. Following his PhD (Leiden University) he was a member of the Medical Faculty of the University of Surinam, South America (Clinical Physiology). He joined Organon International in The Netherlands in 1976 to hold positions in neurophysiology, clinical research and clinical information management. He held a teaching position at the Technical University Eindhoven in The Netherlands. Prior to his current appointment he was responsible for global clinical data management in Hoffmann la Roche and was based in the USA. He joined the EMEA in March 1996 as Head of Unit, Technical Co-ordination; in this position he initiated, among others, the Agency’s quality management system and the quality review of product information of medicinal products as well as initiatives in relation to e-submissions such as the joint EMEA/EFPIA PIM project. He is also the Programme Director of the Pan European Regulatory Forum (PERF).