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
(ICSRs) published on 7 November 2011, and is now issued as a new GVP guideline, replacing the CHMP guideline as of 22 November 2017. The revision contains the following changes: - Alignment with revision 2 of GVP Module VI; - Update of electronic reporting modalities of ICSRs in the new...
they are designed to operate with a Tray Packaging, Unit Weight is shown on datasheet note for use in a 0.056715 oz, that offers Mounting Style features such as Through Hole, Termination Style is designed to work in PCB, as well as the 4-SIP Module Package Case, it has an Operating Te...
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 ...
Also on 7 June 2013, draft Module XVI on risk minimisation measures was released for public consultation. Both consultations closed on 5 August 2013 and the finalisation process is ongoing. On 12 December 2013, the first chapter with Product- or Population-Specific Considerations was provided in ...
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...