【讨论】Q7官版howtodo来了。。。

zhulikou431

Q7工作小组：良好生产规范指南活性药物成分
报告员报告给资深大律师于2在明尼阿波利斯举行的Q7工作组会议的结果 - 2014年6月5日和进步的ICH Q7的Q＆A文件的发展做出。
常设委员会注意到，该工作小组收集选民意见的第一套23 Q＆As和预期的审查明尼阿波利斯会议后收到的反馈意见。预计第一套Q＆至于草案将在92014年年底根据收到的反馈和它的复杂性最终确定，Q7的工作小组会要求在葡萄牙里斯本，以满足2014年11月第二组问答作为选秀会在4个月每一方在2014年六月底的选区审查。
根据收到的反馈意见，小组建议的资深大律师的提问作为可以直接进入第4步无区域协商的需要。据指出，该集团预计，到2015年六月底完成其对非物质文化遗产答疑随着工作。


Q7 IWG: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
The Rapporteur reported to the SC on the outcome of the Q7 IWG meeting held in Minneapolis on 2 – 5 June, 2014 and progress made in the development of the ICH Q7 Q&A document.
The SC noted that the IWG collected comments from constituencies on the first set of 23 Q&As and anticipated to review the feedback received after the Minneapolis meeting. The first set of draft Q&As is expected to be finalised by the end of September 2014. Depending on the feedback received and its complexity, the Q7 IWG might request to meet in Lisbon, Portugal in November 2014. A second set of draft Q&As would be reviewed by the constituencies of each party by the end of June 2014 during four months.
Based on feedback received, the group proposed to the SC that the Q&As could go directly to Step 4 without the need of regional consultation. It was noted that the group was expecting to finalise its work on the ICH Q&As by the end of June 2015.

幻影

机翻作品？

yuansoul

幻影 发表于 2014-10-9 16:17
机翻作品？

不是，是某版主使用机翻的作品。