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Working Specifications of Technical Evaluation Research Group of Center for Drug Evaluation (Trial)

(Summary description)The Technology Evaluation Research Group of the Center for Drug Evaluation (hereinafter referred to as the "Research Group") is a permanent professional academic organization centered around it, serving drug technology evaluation and discipline construction.

Working Specifications of Technical Evaluation Research Group of Center for Drug Evaluation (Trial)

(Summary description)The Technology Evaluation Research Group of the Center for Drug Evaluation (hereinafter referred to as the "Research Group") is a permanent professional academic organization centered around it, serving drug technology evaluation and discipline construction.

Information

  1. The Technology Evaluation Research Group of the Center for Drug Evaluation (hereinafter referred to as the "Research Group") is a permanent professional academic organization centered around it, serving drug technology evaluation and discipline construction.

  2. In order to ensure the smooth development of the work of the research group, this specification is formulated.

  3. Members of the research group and relevant departments of the center shall implement this specification.

  4. The work of the research group is under the guidance of the Review Management and Coordination Department.

  V. Responsibilities of the Research Group

  1. Responsible for sorting out and researching the common problems of relevant professional technologies and other problems that need to be studied in the review work, and put forward suggestions for handling.

  2. According to the special work needs of the center, provide relevant technical support.

  3. Carry out training or academic activities related to technology evaluation.

  4. Undertake other work arranged by the center.

  6. Position setting within the research group

  Each research group has set up six positions of group leader, deputy group leader, convener, secretary, group member, and coordinator. Among them, each group leader, deputy team leader, coordinator, and 1-2 secretaries, the list of personnel is determined by the director's office meeting; the convener is recommended by each review department and approved by the center director's office meeting; each review department The reviewers of relevant professions are all members of relevant research groups.

  7. Responsibilities of each position in the research group

  1. Each post in the research group should take the initiative to discover, collect and propose common professional and technical issues and other relevant issues that need to be studied in combination with the actual work of the review post, and carry out work in accordance with the prescribed procedures.

  2. In addition to the above-mentioned responsibilities, each post should also perform the following responsibilities:

  Team Leader—received the guidance of the Review Management and Coordination Department. Responsible for organizing and implementing various tasks within the group according to the responsibilities of the group.

  Deputy team leader—to assist the team leader in organizing and implementing various tasks within the team.

  The convener—under the leadership of the team leader, assists the team leader in organizing and completing various tasks required by the team. Responsible for collecting and sorting out the technical issues proposed and discussed by the department or each review post in the department, and submitting suggestions for further research to the department and research group.

  Secretary—Accept the leadership of the group leader and assist the group leader in organizing and completing various tasks within the group. Specifically responsible for the organization of various meetings within the group, the writing of meeting minutes of the group affairs meeting and other related work.

  Team members—accept the leadership of the team leader, participate in group activities, and accept work arrangements within the group.

  Coordinator—responsible for the working relationship between the research group and the Review Management and Coordination Department, and participates in various activities within the group.

  八、研究组应定期召开组务会议。组务会议成员一般包括组长、副组长、召集人、秘书、协调员。会议由组长主持。组务会议原则上每月召开1~2次,遇有特殊情况及时召开。每次会议均应形成“组务会议纪要”,通报组内各成员,并抄送审评管理与协调部和各相关审评部门或组织。

  九、研究组组务会职责

  1、结合本组工作的实际、不同时期工作的特点,制定本组的工作计划,并保证组内日常工作的有序开展。

  2、组织讨论召集人提出的技术问题和进一步的研究建议。

  3、组织确定组内研究课题及研究计划,并组织完成。

  4、组织完成审评管理与协调部安排的研究课题或其他与本组职能有关的工作任务。

  十、研究组基本工作程序

  (一)关于召集人以及组内其他人员提交的技术问题和研究建议的工作程序

  1、研究组定期组织讨论召集人以及组内其他人员提交的技术问题研究建议表(见附件一)中提出的问题。

  2、对于讨论后形成明确处理意见的技术问题,研究组形成结题报告,并参照本程序规定的结题报告生效程序,进行后续工作。

  3、对于讨论后认为需进一步研究的技术问题,可作为研究组研究课题开展相关研究工作。

  (二)关于研究组研究课题的工作程序

  1、研究课题的确定

  (1)研究组在组织讨论组内各成员提出的技术问题和研究建议的基础上,召开研究组组务会讨论确定。此类课题为A类课题。

  (2)研究组根据审评管理与协调部以及中心的安排确定研究课题。此类课题为B类课题。

  2、研究计划的确定

  研究课题的研究计划包括研究课题的负责人、参加人员及研究计划。研究计划须经组务会讨论确定,并报审评管理与协调部备案。审评管理与协调部如有意见,应在三个工作日内予以答复。

  3、形成结题报告

  研究课题负责人按确定研究计划完成相关研究工作后,形成结题报告,交研究组组务会审核。研究过程中,研究组根据工作需要可建议组织召开多种形式与内容的研讨会议(有关要求见附件二)。

  4、结题报告的生效

  (1)结题报告经研究组组务会讨论通过后,交审评管理与协调部审核。

  (2) The Review Management and Coordination Department reports to the leadership of the center for approval and sends it to each review department for implementation or reference. The leaders of the center may refer to the relevant review department for comments or organize a ministerial coordination meeting for further study and deliberation.

  (3) For the final report that needs further study and deliberation, the research group should organize drafting of reply opinions or make revisions according to the opinions put forward by the relevant departments or the ministerial coordination meeting. The coordination department will review and report to the center leader for approval before implementation.

  11. Execution and revision of the final report

  1. Once the final report is approved, all relevant departments should implement it as required.

  2. The research group should take the initiative to organize the convener to collect and sort out the problems and opinions of each review department during the implementation process, organize discussions in a timely manner, and organize the project leader to carry out relevant revision work in accordance with the working procedures stipulated in Article 10 of this specification.

  3. Numbering rules for final report (see Appendix 3).

  12. This specification is interpreted by the Review Management and Coordination Department.

  13. This specification shall come into force on January 27, 2006.

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