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
Module IV on pharmacovigilance audits and module XV on safety communication will be open for public consultation until 21 September 2012. The first six modules of the guideline were released in June 2012,* and the remaining five modules are expected later in the year. Key words Pharmacovigilance...
(评论截止日期) 2016年5月31日修订草案2由机构与联合国合作完成 成员国 2017年3月9日欧盟体系药物警戒协议修订草案2修订草案监督组织(EU-POG) 2017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 2017年3月28日修订2生效日期* 2017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...
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 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 III on pharmacovigilance inspections and Module X on processes for additional monitoring of medicinal products were released on 27 June 2012 for public consultation until 24 August 2012, and Module IV on pharmacovigilance audits and Module XV on safety communication were released on 26 July ...
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 agreed by ERMS FG 24 January 2012 Draft...
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...
药物警戒实践指南GVP-module-5-risk-management-systems-rev-2_en.pdf,28 March 2017 EMA/838713/2011 Rev 2* Guideline on good pharmacovigilance practices (GVP) Module V – Risk management systems (Rev 2) Date for coming into effect of first version 2 July 201