| 120-page Japan Monitor document. Single user license. Every year the regulatory and pharmaceutical authorities in Japan are organizing periodic meetings on topics such as new drug approvals, ICH, safety and QA of the pharmaceuticals and medical devices. The current report is a compendium of the summary reports on the 18th, 19th, 20th and 21st “New Drug Evaluation Division Information Meeting" held in Tokyo from the Spring of 2004 to the Spring of 2005. The report is compiled and published by Jouhou Koukai Publishing. For the first time in English the program and the key announcements, formatted, indexed, annotated, hyperlinked and illustrated with figures, tables, editor's notes, references. Key topics – consultations and other functions of the PMDA, new drug review and approval, CTD and eCTD, pediatric trials, investigator-initiated trials, pharmacogenomics, GCP compliance, clinical trials under the new Japanese regulations, biostatistics, risk communications, the Government approach to the unapproved medicinal products, especially for advanced anti-cancer therapy, future clinical trials under the "Three-year Clinical Trials Revitalization Plan". Jouhou Koukai Publishing is a Jouhou Koukai business: pharmaceuticals, medical devices, drug approval, regulations, clinical trials, Japan pharmaceutical affairs, and global and Japanese regulatory affairs. Retrieval and consulting on drug approval and technical documents disclosed in Japan. (ISSN 1550-3429) Copyright © JKS LLC 2005. |
