F1: OPENING REMARKS, OVERVIEW. F2: SECUREMENT OF SAFETY IN EARLY CLINICAL TRIALS - IN LINE WITH ICH-M3 AND THE RECENT EMEA POSITION PAPER. F3: PRECLINICAL STUDIES REQUIRED FOR SINGLE MICRODOSE CLINICAL TRIALS AND CONCEPT OF SECURING SAFETY. F4: 'REGULATORY SUBMISSION WORK' (RSW). A PACKAGE DESIGNED BY GE HEALTHCARE TO SERVE THE CARBON-14 HUMAN ADME STUDY MARKET. F5: MICRODOSING TECHNIQUES IN EXPLORATORY DEVELOPMENT. F6: HUMAN RADIOLABLED STUDY IN EARLY STAGE OF DRUG DEVELOPMENT -APPLICATION OF ACCELERATOR MASS SPECTROMETRY(AMS) IN PHARMACOKINETIC STUDY OF [14C]Y-700, A NOVEL XANTHINE OXIDASE INHIBITOR-. F7: DRUG EVALUATION IN THE LIVING HUMAN BODY USING POSITRON EMISSION TOMOGRAPHY. F8: REFORMATION OF ETHICS COMMITTEE SYSTEM IN EU AND UK AND PROPOSAL FOR JAPAN. / F1: はじめに F2: 早期臨床試験における安全性の確保について,ICH-M3から最近のEMEA通知を踏まえて F3: Microdosingにおける安全性の確保と考え方 F4: Hot化合物の品質基準 F5: Microdosingによるヒトにおける初期探索試験 F6: 追加発言 F7: PETによるヒトin vivoでの薬物の評価 F8: EU,英国の倫理審査システムの改革と日本への提言