Art

J-GLOBAL ID：201502290911194403   Reference number：15A0355577

“Pharmaceutical Risk Management Plan: Current Status and Future View” 4. Lifecycle Risk Assessment: Proposals from the CIOMS Working Group VI and the PhRMA Safety Planning, Evaluation, and Reporting Team

医薬品リスク管理計画(RMP)の現状と今後 4.Lifecycle Risk Assessment-CIOMS Working Group VI報告書および米国研究製薬工業団体SPERTによる提案-

Author (1)： URUSHIHARA HISASHI (慶応大 薬)
Material： 薬剤疫学  (Japanese Journal of Pharmacoepidemiology)
Volume： 19  Issue： 2  Page： 123-132  Publication year： Feb. 20, 2015 
JST Material Number： L4171A  ISSN： 1342-0445  Document type： Article
Article type： 解説  Country of issue： Japan (JPN)  Language： JAPANESE (JA)

Thesaurus term： human(primates) ,...
Semi thesaurus term： working group ,...

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JST classification (2)： Pharmacy in general  (GU01010G) ,  Medical systems  (GB04020H)

Reference (15)：

• 1) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Final Concept Paper, E2E: Pharmacovigilance Planning, Dated and endorsed by the Steering Committee on 11 September 2002.
• 2) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline E2E: Phramacovigilance Planning. Step 4. 2004
• 3) 厚生労働省医薬食品局安全対策課長,医薬食品局審査管理課長.医薬品リスク管理計画指針について. 薬食安発0411第1号,薬食審査発0411第2号,平成24年4月11日.
• 4) Council for International Organizations of Medical Sciences, Working Group VI. Management of Safety Information from Clinical Trials --Report of CIOMS Working Group VI. Geneva: 2005.
• 5) The U.S. Food and Drug Administration. Guidance for Industry: Premarketing Risk Assessment. March 2005.

Terms in the title (8)： 医薬品リスク管理計画 ,  RMP ,  現状 ,  報告書 ,  米国 ,  研究 ,  製薬工業 ,  提案