Terms of Reference

Organization Name: Global Coalition for Regulatory Science Research (GCRSR)

Project Name: Executive Committee

Version Number and Date: Version 4, August 2024

Previous Version and Date: Version 1 (2014), Version 2 (2018), and Version 3 (2021)

Authority

The Executive Committee (or the Committee) is established under the GCRSR. The Committee is a decision-making body to guide Project development under the GCRSR. The Committee will operate according to these Terms of Reference.

Purpose

The Executive Committee was established by the GCRSR to represent the government agencies in their respective countries. Its objective is to guide the Project development that forges international partnerships and collaborations with aims at advancing regulatory science research applicable to the public health impacts of food and therapeutic products.

Role of the Committee

The Committee will conduct promotion and facilitation of regulatory science research needed to support regulatory decision making, establishment of best practices to understand and interpret data from innovative technologies, and facilitation of translation of basic science innovations into regulatory applications applicable to public health impacts of food and therapeutic products. The Committee will:

• Establish a sustainable annual conference of Global Summit on Regulatory Science (GSRS).

• Facilitate global collaborations in advancing regulatory science.

• Identify specific topics of regulatory science to be considered by the GCRSR and address the critical research, scientific questions and consensus building needs.

• Recommend strategies for implementation to facilitate development of new technologies from basic research to regulatory decision-making tools.

• Develop collaborative mechanisms for training regulatory scientists in a global environment.

• Evaluate the impact of the GCRSR activities.

• Other activities as agreed to by the Committee.

Boundaries

The Committee (and GCRSR) will focus on scientific issues related to advancing regulatory science applicable to food and therapeutic products.

Committee

The Committee is comprised of representatives of government agencies responsible for the regulation of food and therapeutic products that are listed and updated in Appendix A. An agency that is not a current GCRSR member may request committee membership or be invited to join by the Committee. New members will be added at the discretion of the Committee.

GCRSR Committee Member and their Representative and Observers:

•Committee Member – The person who is designated by their agency to vote on behalf of the agency.

•Agency Representative – The person who is delegated by the Committee Member to attend and vote on behalf of their agency in the absence of the Committee Member.

•Observers – Those who attend to observe and engage in discussions (non-voting).

The Committee is chaired by the Chair and Vice-Chair. The Chair serves a five-year term, and the Vice-Chair serves a three-year term. Both positions may be renewed for one term each upon approval by the Committee.

Review

The terms of the reference for the Committee will be reviewed every two years following its establishment on 10 September 2013.

Modus Operandi

Secretariat: The elected Chair will provide a Secretariat for the Committee for the duration of their term. The Secretariat will arrange meetings, circulate meeting agendas and papers, prepare outcome notes, and document the Committee’s activities including those associated with the GCRSR working groups. The Secretariat will also assist the scientific program committee of the GSRS to develop GSRS materials.

The Secretariat will coordinate the development of public facing communications regarding GCRSR activities including those related to the GSRS and working groups. In addition, the Secretariat will communicate with the Committee and other interested parties in a timely manner and will post materials to the website.

Committee Meetings: The Committee will meet at least biannually with one meeting being held in conjunction with the annual GSRS conferences. The Committee will utilize both face-to-face and electronic opportunities for meetings.

The Chair and Vice Chair will engage on development of the agendas and co-chair the Executive Committee meetings, as well as provide leadership and chair sessions during the annual GSRS conference.

Working Groups and Technical Taskforces: as appropriate, the Committee may establish working groups and technical taskforces to assist in its activities, which will be chaired by members of the Committee. Working groups and taskforces should report regularly to the Committee and present proposed strategies and activities for endorsement by the Committee.

Membership Application and Approval:

•Eligibility Criteria: Government agencies engaging in either research or regulation of food or therapeutics.

•Application Initiation: Applications can be initiated by either a “Letter of Intent” from prospective members or a “Letter of Invitation” from the GCRSR.

•Membership Review: Membership applications will be reviewed in accordance with consensus among the Committee on one of the processes: (1) Electronically voting to proceed with an invitation without further discussion, or (2) Scheduling a Committee meeting to discuss any potential concerns and/or gathering additional information required for the membership review.

•Membership Approval: It follows the decision-making process outlined below.

GSRS Conference Host Application and Approval:

•Eligibility Criteria: Either member or non-member government agencies engaging in regulatory science research and regulation of foods and therapeutic products. Other government agencies may be considered at the discretion of the Committee.

•Application Initiation: Applicant must submit a Letter of Intent (LOI Template in Appendix B) which is a non-binding commitment on the part of the applicant.

•Application Review: The applicant(s) will present the proposal to the Committee with information including, but not limited to, (1) venue, (2) theme, and (3) feasibility and capability, especially regarding financial support.

•Application Approval: It follows the decision-making process outlined below.

Decision Making: Decisions of the Committee will be made by consensus. If consensus cannot be reached, a decision will be made by a 75% majority vote, with each agency entitled to cast one vote.

Term of Reference Review: The Terms of Reference for the Committee will be reviewed every two years.

Decision making

Decisions of the Committee will be by consensus unless otherwise decided by the Committee. If consensus cannot be reached on a matter, the Committee will vote on the matter with the majority view prevailing, where each member country or union casts one vote after coming to consensus within their jurisdiction.

Confidentiality

Each Committee member will maintain the confidentiality of information in accordance with their respective laws.