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 ,...
Semi thesaurus term： working group ,...

Register(free) or Log In to access     To see more with JDream III (charged).   {{ this.onShowAbsJLink("http://jdream3.com/lp/jglobal/index.html?docNo=15A0355577&from=J-GLOBAL&jstjournalNo=L4171A") }}

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