CTD格式、即eCTD(ElectronicCommonTechnicalDocument)的落實。自西元2009 年7月1日起,關於以中央統一程序遞交之送審文件,EMA強烈建議以eCTD格 式編寫送審文件,並且僅以電子化方式遞送。美國FDA亦積極推動eCTD送件, 並公布相關之指引和操作說明供申請者參考。
978-3-319-17590-4_5 Chapter 5 The Current Status of the Common Technical Document Introduction The most signifi cant regulatory initiative that the GCC member states have proac-tively implemented as part of their goal to standardise their regulatory systems is the Common Technical Document (CTD...
Comparison of the deficiencies with those reported by other agencies such as the USFDA, EMA, TFDA and WHOPQTm are discussed with similarities outlined. Conclusions:The overall top five most common deficiencies observed by SAHPRA were extensively discussed for the generic products. The findings provide...
In one consulting engagement, EMA provided the following structure for orchestrating CI interdependencies supporting a basic, e-mail service (Figure 13.1). The map below is a useful generic look at aggregating CI groups into a meaningful service model, without eliminating the options for more detaile...
The International Conference on Harmonisation’s electronic Common Technical Document (eCTD) endeavors to significantly change the pharmaceutical submission process. After decades of using paper, the goal is the electronic transfer of drug applications and their review across submission formats, procedures, ...
For a less technical description of the paper and how it should—and should not—be interpreted, see the Frequently Asked Questions (FAQ) section in theSupplementary Informationand Box1. Box 1 Understanding genetics and income: a cautionary overview ...
Tillema, J. Arts Dealing with interrelatedness and fragmentation in road infrastructure planning: An analysis of integrated approaches throughout the planning process in the Netherlands Planning Theory & Practice, 17 (3) (2016), pp. 421-443, 10.1080/14649357.2016.1193888 View in ScopusGoogle ...
Babalola O, Ibem EO, Ezema IC (2019) Implementation of Lean practices in the construction industry: a systematic review. Build Environ 148:34–43. https://doi.org/10.1016/j.buildenv.2018.10.051 Article Google Scholar Bajjou MS, Chafi A, En-Nadi A (2017) A comparative study between ...
Document S1. Figures S1–S7 and Table S1 Data S1. RNA-seq of siNUP93 and control siRNA treated in MDA-MB-231 cells, related to Figure 3 Data S2. Proteomic analysis of nuclear and cytosolic fractions from MDA-MB-231 cells pre-treated with siNUP93 or control siRNA, related to Figures...
James’s Hospital, Ireland; Roberto Rondelli, AIEOP (Associazione Italiana Ematologia Oncologia Pediatrica); Eleonora Gambineri, Clementina Canessa, Florence, University of F, Dep. Pediatrics; Anna Villa, Maria Cristina, Pietrogrande, Milano, ITB, Segrate; Claudio Pignata, Naples, Pediatrics, Italy...