药物警戒实践指南GVP-module-vi-addendum-i-duplicate-management-suspected_en.pdf,28 July 2017 EMA/405655/20 16 Guideline on good pharmacovigilance practices (GVP) Module VI Addendum I – Duplicate management of suspected adverse reaction reports Draft fina
GVP-药物警戒体系及质量体系(模块一).pdf 22 June 2012 EMA/541760/2011 Guideline on good pharmacovigilance practices (GVP) Module I – Pharmacovigilance systems and their quality systems Draft finalised by the Agency in collaboration with Member States and 19 January 2012 submitted to ERMS FG Draft ...
V.B.5.5. RMP part II, module SIV “Populations not studied in clinical trials” ... 14 V.B.5.6. RMP part II, module SV “Post-authorisation experience” ... 15 V.B.5.7. RMP part II, module SVI “Additional EU requirements for the safety specification” 15 V.B.5.8. RMP part...
Module VI--management and reporting of adverse reactions to medicinal products. http://www.ema. europa.eu/docs/en_GB/document_library/Scientific_guideline/ 2012/06/WC500129135.pdf. Published June 22, 2012. Accessed December 2, 2013.Good pharmacovigilance practices (GVP). . 2012...
* Note: Revision 1 is a major revision with modifications throughout and contains the following: - Revised definition and process for emerging safety issues, previously addressed in GVP Module VI (IX.A.1.1. and IX.C.2.); - Streamlined information on scientific aspects of signal management (...
Module XIII on incident management is no longer under development. All topics originally intended to be covered in this module are now to be included in module XII.Product- or population-specific considerations The chapters on product- or population-specific considerations are currently under ...
Module VIII Revision 1 and its Addendum Revision 1 as well as in Annex II – Template for the PSUR Cover Page Revision 1 were published on 25 April 2013. On 7 June 2013, the draft revision 1 of Module VI on the management and reporting of adverse reactions was released for public ...
balance of a medicinal product . This Module provides part icular guidance on t he use of addit ional risk 69 minimisat ion measures and on t he select ion of t ools. However, it should be underst ood t hat t he 70 principles for evaluat ing t he effect iveness of risk minimisat...
2021年3月9日欧盟体系药物戒备协议修订草案2修订草案监视组织〔EU-POG〕 2021年3月23日执行主任通过的第二次修订草案作为最终决定 2021年3月28日修订2生效日期* 2021年3月31日注:申请首次上市授权申请的RMP和申请GVP Module V Rev 1的D121申请将被承受为期6个月,其他所有RMP申请〔包括在加速评估下的初始申请的...
需要金币:*** 金币(10金币=人民币1元) 药物警戒实践指南GVP-module-5-risk-management-systems-rev-2_en.pdf 关闭预览 想预览更多内容,点击免费在线预览全文 免费在线预览全文 28 March 2017 EMA/838713/2011 Rev 2* Guideline on good pharmacovigilance practices (GVP) Module V – Risk management systems...