首页 > GHTF标准 > Strategic AssessmentIMDRF/RPS WG/N32

IMDRF/RPS WG/N32 FINAL: 2015 Strategic Assessment of Electronic Submission Messaging Formats - PDF (242Kb)

赵静曼 4/9/2022 浏览 282 IMDRF/RPS WG/N32 全球

标准简介

Strategic Assessment of Electronic Submission Messaging Formats - PDF (242Kb)[附网盘链接]是IMDRF RPS WG发布的GHTF标准，适用于全球。

标准截图

Strategic Assessment of Electronic Submission Messaging Formats - PDF (242Kb)[附网盘链接]
Strategic Assessment of Electronic Submission Messaging Formats - PDF (242Kb)[附网盘链接](截图)

 

标准文档说明

标准文档类型为Strategic Assessment of Electronic Submission Messaging Formats - PDF (242Kb)[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。

标准部分原文

The summary below includes views expressed during all discussions for full transparency and an

accurate view of the diverse perspectives. As a result the final scores are based the weighted average and

do not represent individual stakeholder viewpoints.

The main concern within industry remains the cost to implement and maintain software tools that may

be required for any option. Many companies with simple submissions in particular do not see any

benefit to the additional costs they feel would be incurred for all options.

Since consideration of options 3 and 4 are currently in an early exploratory stage, it was understood

throughout industry discussions that a robust cost-benefit analysis is not possible at this time. For

industry stakeholder adoption this is a significant consideration, and will need to be assessed once

sufficient implementation planning has been done to support such an analysis. Industry views this cost-

benefit analysis as a critical step.

Efficiently produce submissions for multiple regions without managing multiple submission

creation processes, and software tools

Although some companies could see the potential benefit of meeting this objective, there were

some that did not view this as a priority. Companies who operate in a de-centralized fashion

today manage multiple processes and tools as a result of the way they are structured.

Introduction of a harmonized submission format is not likely to change that. Among those

companies, some viewed all options as adding unnecessary complexity.

There were many companies who felt the move to a harmonized format is worthwhile. Although

there was concern that even with use of a messaging standard like RPS, each region may impose

unique implementation requirements that would undermine this objective. Regional differences

in eCTD implementation were cited as an example.

Some felt that Option 4 would only be the best choice if regional variance could be eliminated,

and tools used to create the RPS format also could produce PDF and other paper format

submissions to meet requirements in countries that do not recognize the format chosen by

IMDRF.

Generally, companies with simple submissions preferred use of the folder structure.

Enable a clear view to the lifecycle of Application content over time, as well as the ability to

quickly see the most current version of an Application.

Companies with complex submissions who currently manage submissions with many

supplements or change submissions that occur over time saw the benefit of content lifecycle

tracking. This clearly resonated with those who manage multiple PMAs in the US, and with

European companies who manage design dossiers.

Some companies noted that the ability to fully take advantage of lifecycle tracking will depend

on the tools available to industry, and on the cost of those tools.

Some did not see that Option 2 provided any ability to manage lifecycle of submission content.

Others noted that since RPS is being adopted by ICH as eCTD v4.0, it clearly meets

requirements for submission lifecycle tracking.

2 October 2015 Page 19 of 36

网盘链接

百度网盘：https://pan.baidu.com/s/1dyPlF1-WcbOaEe2CeTPpVw
提取码：u73e

【温馨提示】大资料ISO是提供信息发布的专业信息类网站，所有内容均由用户发布，不代表本站观点，本站亦不存储所涉及的文件及资料。如有【免费资料】以及【付费资料】,请用户根据自己的需求，自行判断是否需要获取。如有交易诈骗、内容侵权可发送邮件至kf@dzl100.com，我们审查后若发现情况属实，会立即对相关内容进行删除处理。

加载用时：155.097 毫秒

相关评论

相关文章