Trilateral Cooperation Charter

Between

The Health Products and Food Branch,
Health Canada
Canada,

The Food and Drug Administration,
Department of Health and Human Services
The United States of America,

and

The Federal Commission for the Protection from Sanitary Risks,
Secretaria de Salud
Mexico

Revised in 2005

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Table of Contents

Trilateral Cooperation Charter

PURPOSE

MISSION

MEMBERSHIP (Participants to the Trilateral Cooperation)

STRATEGIC OBJECTIVES

PRINCIPLES

GOVERNANCE STRUCTURE

A. Heads of Delegation
B. Steering Committee
C. Working Groups
D. Country Coordinators (Secretariat)

SCOPE OF WORK

CRITERIA FOR IDENTIFYING ISSUES FOR DISCUSSION

MEETINGS

Agenda Development and Dissemination

SUMMARY OF OPERATING PROCEDURES

Meeting Process
Decision Making
Responsibilities of Members
Sub-committees
Amendments

APPENDIX A: GOVERNANCE STRUCTURE

APPENDIX B: TERMS OF REFERENCE OF THE WORKING GROUPS

Trilateral Cooperation Charter

PURPOSE

To increase communication, collaboration, and the exchange of information among the three countries in the areas of drugs, biologics, medical devices, food safety and nutrition to protect and promote human health.

MISSION

To protect and promote public health through a trilateral forum that shares information and works collaboratively on issues of mutual interest.

MEMBERSHIP (Participants to the Trilateral Cooperation)

*Signatories

This Charter recognizes that others may be invited to participate (based on the issues before the Trilateral Cooperation). It also recognizes that non-signatory organizations have mandates in the areas of drugs, medical devices, food safety, and nutrition (to protect and promote human health) as well as in the areas of general marketplace competition and consumer benefit

¹ Health Canada and the CFIA share unique and complementary roles and responsibilities. Health Canada is responsible for food safety and nutrition policies, standards and regulations, including related labeling issues, while the CFIA is responsible for food inspection and compliance activities, as well as the development of regulations and policies related to other food labeling and compositional standards.

STRATEGIC OBJECTIVES

In pursuit of this mission, members intend to actively engage in achieving the following strategic objectives:

• Identifying and solving problems;
  
  
• Sharing information and best practices, and establishing harmonized positions on issues of mutual interest;
  
  
• Identifying emerging issues of common interest;
  
  
• Promoting capacity building;
  
  
• Developing confidence/capacity and trust among members of the trilateral;
  
  
• Increasing public confidence;
  
  
• Developing partnerships; and Developing mechanisms for cooperation and working collaboratively to implement solutions for issues of mutual interest.

PRINCIPLES

To achieve these objectives, the Parties to the Trilateral Cooperation should be guided by the following principles:

• A focus on health and safety issues;
  
  
• The advancement of public health;
  
  
• Equal participation for all stakeholders;
  
  
• Serving the interests of all three countries; and
  
  
• The use of joint problem-solving techniques and consensual decision-making processes.

GOVERNANCE STRUCTURE

A. Heads of Delegation

The Trilateral Heads of Delegation Team is the decision-making body of the Trilateral Cooperation. It comprises the leaders of HPFB (Assistant Deputy Minister), the FDA (Commissioner of Food and Drugs), and COFEPRIS (Federal Commissioner). The role of the Trilateral Heads of Delegation is to provide overall leadership for and direction to the Trilateral Cooperation.

B. Steering Committee

Reporting to the Heads of Delegation, the Steering Committee sets the agenda for each meeting in line with the principles and strategic objectives, focusing on priorities that benefit all countries. The Committee provides leadership to the Working Groups and recommends high-level policy issues to the Heads of Delegation. As well, it identifies and discusses new and emerging issues confronting the three countries.

The Steering Committee consists of an equal number of members from each country, with the selection being the responsibility of the individual countries. The Steering Committee is led by country Co-chairs who serve as liaisons to the Working Groups.

Specifically, the Steering Committee

• draws upon the expertise of its members and others to provide advice and recommendations on high-level issues to the Heads of Delegation;
  
  
• garners support and promotes the Trilateral Cooperation by communicating objectives and accomplishments to senior management in its respective organizations;
  
  
• establishes ad hoc sub-committees and/or task forces to undertake specific work;
  
  
• invites experts to submit information to the Committee, when and as required ;
  
  
• is the forum for joint proactive Trilateral Cooperation planning; and
  
  
• refers unresolved issues to the Heads of Delegation, as required .

C. Working Groups

The Trilateral Cooperation undertakes its work through Working Groups. Currently, the Trilateral Cooperation has five Working Groups:

1. Canada-US-Mexico Compliance Information Working Group (CUMCIG): Its purpose is to share information and explore areas of mutual interest on the continuum of compliance decision-making approaches².
   
   
2. Emergency Preparedness and Response (EPR) Working Group: Its purpose is to enhance the ability to respond to emergencies related to foods, drugs, medical devices, biologics and veterinary products that may affect more than one participating country.
   
   
3. Laboratory Cooperation Working Group: Its purpose is to establish and maintain cooperation in the area of regulatory laboratory operations. Through continual discussions, this group is expected to share information with a view to building confidence in our respective analytical results.
   
   
4. Mexico-US-Canada Health Fraud (MUCH) Working Group: Its purpose is to maintain a formal framework for cooperation in combating health fraud and to identify appropriate lines of communication to ensure a continual exchange of information on compliance and enforcement activities among the three countries.
   
   
5. Training Working Group: Its purpose is to share existing training information, establish a communication strategy between the Training Working Group and the other Working Groups, and to assist in identifying training needs of staff who will be engaged in Trilateral work.

Each country shall identify a lead representative and an alternate representative for each of the working groups. Each country will be assigned the responsibility of leading the work of specific working groups based on the following three-year rotation scheduled established by the Steering Committee in 2005:

The responsibilities of leading a working group shall include:

• chairing the teleconferences/meetings;
  
  
• providing secretariat support to their assigned working groups (as defined below);
  
  
• developing annual plans to implement the objectives of their assigned working groups; and
  
  
• reporting, on behalf of the Working Group, to the Steering Committee and the Heads of Delegation.

The designated lead country will provide secretariat services to the Working Group. These services comprise the following:

• Agenda: Members shall be canvassed in advance of regularly scheduled meetings and an agenda made available a minimum of five working days in advance of each meeting.

• Logistics: The lead country shall assume responsibility for requirements pertaining to teleconferences or meetings. Members shall be responsible for their own travel and accommodation arrangements.

• Interpretation/Translation: The lead country shall provide Spanish /English interpretation during the teleconferences/meetings and translation of key documents as required;

• Meeting Summary: A record of the meetings shall be kept and held to the appropriate level of detail required to summarize effectively the proceedings and to reflect decisions taken.

• Disclosure: Members of the Working Group subscribe to the principles of accountability and disclosure. However, in view of the confidential information discussed and exchanged at the Working Group meetings that relate to ongoing investigations by law enforcement and regulatory agencies, the meeting summaries shall be kept confidential.

² Continuum of compliance decision-making approaches starts from the identification of the issue to the mitigation of risks actions (including risk assessment, risk management, surveillance, voluntary compliance and enforcement).

D. Country Coordinators

Each country will identify a country coordinator to oversee the overall management of and provide support services to the Trilateral Cooperation. Specifically, the country coordinators will:

• ensure horizontal management and linkages among the various working groups of the Trilateral Cooperation;
  
  
• provide advice and support to the Steering Committee;
  
  
• provide advice to their respective countries' lead representatives of the working groups;
  
  
• develop agendas and reports for the Trilateral mid-year (Spring) and annual (Fall) meetings; and
  
  
• provide secretariat support, as appropriate, to their respective countries' assigned working groups (i.e., scheduling and drafting the agendas and minutes for the teleconferences/meetings).

SCOPE OF WORK

The Trilateral Cooperation serves the mutual interests of all three countries and provides a forum for participants to discuss effective means for achieving its mission. Joint problem-solving techniques and consensual decision-making processes are used in reaching resolution of issues in a way that advances public health and gives consideration to the economic impact of health fraud.

To avoid duplication and overlap, the Trilateral Cooperation should not deal with issues that are being discussed in other fora unless requested to do so as a means of solving a specific problem affecting the three countries or unless directed to do so by the Heads of Delegation.

The Committee recognizes that the work under the Trilateral Cooperation is not a substitute for bilateral cooperation, nor does it impose obligations on its counterparts. Countries should use existing and new fora to discuss bilateral issues.

CRITERIA FOR IDENTIFYING ISSUES FOR DISCUSSION

To prioritize its discussions, the Steering Committee uses the following criteria in selecting issues for discussion. Each issue must

• be a public health concern;
  
  
• be of common concern to all three countries;
  
  
• be solvable with realizable outcomes and within a reasonable time frame; and
  
  
• not detract from discussions or processes in other fora.

MEETINGS

The Steering Committee (and the Working Groups - as appropriate) should meet in the spring and fall of each year, with any additional meetings (teleconferences or videoconferences) called by the Steering Committee as required. Each country will host the meetings on a rotating basis (Canada-Mexico-US). The host country is responsible for all scheduling, logistics, and management of the meetings.

The spring meeting will be devoted to reviewing progress, resolving any impediments to progress, and evaluating accomplishments.

The fall meeting, which includes a meeting of the Heads of Delegation, will be devoted to a year-end review, the assessment of outcomes, the identification of new issues, and the setting of priorities for the following year.

A tracking system (Action Plan) is to be developed by each Working Group to track major projects including action items, performance measurements, progress and accomplishments. The system should be updated regularly with summaries provided to the Steering Committee and the other Working Groups ahead of the spring and fall meetings. The Steering Committee expects to use these meetings to determine whether to renew its procedures and/or to make changes in any aspect of the partnership.

A. Agenda Development and Dissemination

Meeting agendas (subject to the Steering Committee's final approval) are developed by the host country in collaboration with the other two countries. All potential agenda items should be submitted to the country coordinators who will forward them to the host country. The host country develops a mutually agreeable agenda for the spring and fall meetings. The final agenda should be distributed to all participants at least 10 working days prior to the meeting.

For issues that require the Steering Committee to make a decision, all related information must be distributed to participants no later than 10 calendar days prior to the meeting.

SUMMARY OF OPERATING PROCEDURES

A. Annual Meetings Process

1. Country Coordinators are responsible for coordinating input for the development of agendas, and for selecting facilitators and scribes for the meetings.
   
   
2. New business agenda items may be proposed by any member of the Steering Committee or Working Groups and should be submitted for consideration to the Coordinators for inclusion on the agenda 14 days before the meeting.
   
   
3. Meetings are to be held as required, but at least twice each year (spring and fall).
   
   
4. The Steering Committee may allot time for presentations by non-members regarding agenda items.
   
   
5. Meeting records should clearly indicate any members responsible for leading any action arising along with report back dates.

B. Decision Making

6. All decisions are to be made by consensus. Consensus is defined as an understanding by all members of the group, arrived at through discussion and compromise. Although it may not be each member's preferred result, it is a result that all members can "live with" and support.

C. Responsibilities of Members

7. Each member has a responsibility to participate actively in discussions and decision-making.
8. Each member of the Steering Committee and the Working Groups share responsibility for the effectiveness of the group's collaborative problem-solving and decision-making processes.
9. All members of the Steering Committee, regardless of whether they are present at meetings, are expected to support the Committee's decisions and assist in their implementation.

D. Sub-committees

10. The Steering Committee may establish sub-committees as necessary to undertake specific work.

E. Amendments

11. The Steering Committee, through mutual written consent and approval by the Heads of Delegation, may alter, amend, or revoke the Trilateral Cooperation Charter or any of its operating procedures at any time and may adopt additional procedures as it deems necessary.

Signed on this twenty-seventh day of February 2004, in the English, French and Spanish languages, each version being equally valid.

For The Health Products and Food Branch
HEALTH CANADA
CANADA:

Original signed in February 2004

Diane C. Gorman
Assistant Deputy Minister
Head of Delegation ( Canada)

For The Food and Drug Administration
DEPARTMENT OF HEALTH AND HUMAN SERVICES,
THE UNITED STATES OF AMERICA:

Original signed in February 2004

Mark B. McClellan, M.D., Ph.D.
Commissioner of Food and Drugs
Head of Delegation ( United States of America)

For The Federal Commission for the Protection from Sanitary Risks
SECRETARIA DE SALUD
MEXICO:

Original signed in February 2004

Ernesto Enríquez Rubio
Federal Commissioner
Head of Delegation ( Mexico)

APPENDIX A: GOVERNANCE STRUCTURE

APPENDIX B: TERMS OF REFERENCE OF THE WORKING GROUPS

CANADA-U.S.-MEXICO COMPLIANCE INFORMATION Working Group (CUMCIG) -- TERMS OF REFERENCE

Purpose

The Canada-U.S.-Mexico Compliance Information Working Group (CUMCIG) will develop a trusted compliance information network resulting from building confidence between the three countries on their regulatory processes and decision-making practices³ which would inform compliance decisions in each country to protect public health.

³ Regulatory processes and decision making-practices include risk assessment, risk management and compliance approaches.

Objective

CUMCIG will share information and explore areas of mutual interest on the continuum of compliance decision-making approaches⁴ related to human drugs, and food⁵ to the extent compatible with the countries' respective statutory authorities.

⁴ Continuum of compliance decision-making approaches starts from the identification of the issue to the mitigation of risks actions (including risk assessment, risk management, surveillance, voluntary compliance and enforcement).

⁵ Food as defined by Codex Alimentarius. Building on the successes of the implementation of the objective in the human drugs and food commodities, CUMCIG will re-assess the potential of including other commodities, such as medical devices, in October 2005.

Membership

The CUMCIG Working Group shall consist of the following:

• Representatives of the regulatory agencies relevant to compliance and enforcement activities from the three signatory countries; and
  
  
• Representatives from other bodies, as deemed appropriate by each member country.

Each country shall identify a lead representative and an alternate representative to the Working Group. The leads and their alternates will be individuals with relevant expertise.

Structure

Each country will be assigned the responsibility of chairing CUMCIG based on a three-year rotation scheduled identified in Section 6C of the Charter. The designated lead country will chair the meetings and conference calls; report, on behalf of the Working Group, to the Trilateral Steering Committee; and provide secretariat services to the Working Group (refer to Section 6C of the Charter).

Issues requiring follow-up may be delegated to ad hoc groups. Individual participants brief their respective organizations on the discussions and action items resulting from the CUMCIG meeting.

Decisional Process

Decisions shall be based upon consensus rather than majority vote.

Meetings Schedule

The Working Group shall conduct its business on a continual basis and shall meet in person two times a year at the Trilateral meetings as stipulated in Section 9 of the Charter and conduct regular business via e-mails, conference calls or video-teleconference as often as the Working Groups deems necessary to meet its objectives.

Operating Principles

The CUMCIG Working Group's activity will be based on the following principles:

• An appropriate agenda will be developed jointly. However, the designated lead country will be responsible for developing, distributing, and maintaining the Action Items. The agenda will be made available a minimum of five working days in advance of each meeting.
  
  
• The Working Group will not duplicate work being carried out by other Working Groups or committees.
  
  
• The agency raising an issue shall lead the discussion.
  
  
• The Working Group should focus on the exchange of information on compliance and enforcement activities. This exchange may be of a general nature, health protection policy issues, safety and quality issues or specific issues (e.g., canned mushrooms).
  
  
• The Working Group should limit the number of issues discussed at a meeting and should establish priorities jointly.
  
  
• The Working Group should identify each issue to be resolved, with defined objectives, an outline of the working arrangements, and a time frame for resolution of a given issue.
  
  
• Any structure (e.g., sub-committee, task force, etc.) established to handle a particular issue should be flexible and responsive.

Language

The meetings and teleconferences shall take place in English and Spanish pertaining to the ensemble of the Working Group membership. French interpretation will be available when required. The host country shall be responsible for ensuring simultaneous interpretation as may be necessary.

With respect to press releases, communiqués, and other such materials, each member country shall be responsible for ensuring appropriate translation for dissemination within their own national boundaries, obtaining necessary approvals and/or clearances within mutually agreeable time frames.

EMERGENCY PREPAREDNESS AND RESPONSE ( EPR) Working Group -- TERMS OF REFERENCE

Purpose

The purpose of Emergency Preparedness and Response (EPR) Working Group is to enhance the ability to respond to emergencies related to foods, drugs, medical devices, biologics and veterinary products that may affect more than one participating country.

Objectives

To the extent compatible with their respective statutory and regulatory authorities, policies and other priorities, each member country shall:

• Develop procedures to respond to emergencies within the trilateral context.
  
  
• Share information regarding emergency preparedness and response management.
  
  
• Share information regarding National and Agency response plans, exercises and lessons learned.
  
  
• Attain and maintain an optimal level of communication in emergency preparedness and response within the trilateral context.

Membership

The EPR workgroup shall consist of the following:

• Representatives of the regulatory agencies relevant to emergency preparedness and response activities from the three signatory countries; and
  
  
• Representatives from other bodies as deemed appropriate by each member country.

Each country shall identify a lead representative and an alternate representative to the Working Group.

Structure

Each country will be assigned the responsibility of chairing the Working Group based on a three-year rotation scheduled identified in Section 6C of the Charter. The designated lead country will chair the meetings and conference calls; report, on behalf of the Working Group, to the Trilateral Steering Committee; and provide secretariat services to the Working Group (refer to Section 6C of the Charter). Issues requiring follow-up may be delegated to ad hoc groups.

Decisional Process

Decisions shall be based upon consensus rather than majority vote.

Meetings Schedule

The Working Group shall conduct its business on a continual basis and shall meet in person two times a year at the Trilateral meetings as stipulated in the Section 9 of the Charter and conduct regular business via e-mails, conference calls or video-teleconference as often as the Working Groups deems necessary to meet its objectives.

Operating Principles

The working group's activities will be based on the following principles:

• An agenda will be developed jointly among all countries. However the chair country will be responsible for developing, distributing and maintaining the action items (i.e. the secretariat).
  
  
• The work group will not duplicate work being carried out by other working groups or committees.
  
  
• The country raising an issue shall lead the discussion.

The Working Group will develop and maintain a yearly plan of activities that will address issues such as a contact list, testing of notification systems, exercise planning and continuous improvement of emergency response procedures.

Language

The meetings and teleconferences shall take place in English and Spanish pertaining to the ensemble of the Working Group membership. French interpretation will be available when required. The host country shall be responsible for ensuring simultaneous interpretation as may be necessary.

With respect to press releases, communiqués, and other such materials, each member country shall be responsible for ensuring appropriate translation for dissemination within their own national boundaries, obtaining necessary approvals and/or clearances within mutually agreeable time frames.

LABORATORY COOPERATION Working Group -- TERMS OF REFERENCE

Purpose

The purpose of the Laboratory Cooperation Working Group (LCG) is to build a trusted analytical laboratory network among the three countries through building confidence in the work of the laboratories to assist each other, especially in times of emergency.

The LCG is also to work closely with and provide support to CUMCIG and MUCH, in their investigations of fraudulent products, counterfeit or unsafe drugs, and shortages of legitimate drugs.

Objectives

To the extent compatible with their respective statutory and regulatory authorities, policies and priorities, each member country shall

• identify and establish lines of communication to ensure a continual exchange of information on laboratory and regulatory science issues among the three countries;
  
  
• identify issues of common concern, and develop and implement approaches for dealing with them in a coordinated manner;
  
  
• explore and develop areas where joint or complementary positions and operations could be of mutual benefit; and
  
  
• support the work of the other Working Groups by providing laboratory support.

Membership

The LCG shall consist of the following:

• Representatives of the regulatory agencies relevant to laboratory activities from the three signatory countries; and
  
  
• Representatives from other bodies, as deemed appropriate by each member country.

Each country shall identify a lead representative and an alternate representative to the Working Group.

Structure

Each country will be assigned the responsibility of chairing the Working Group based on a three-year rotation scheduled identified in Section 6C of the Charter. The designated lead country will chair the meetings and conference calls; report, on behalf of the Working Group, to the Trilateral Steering Committee; and provide secretariat services to the Working Group (refer to Section 6C of the Charter). Issues requiring follow-up may be delegated to ad hoc groups.

Decision Process

Decisions shall be based upon consensus rather than majority vote.

Meetings Schedule

The Working Group shall conduct its business on a continual basis and shall meet in person two times a year at the Trilateral meetings as stipulated in the Section 9 of the Charter and conduct regular business via e-mails, conference calls or video-teleconference as often as the Working Group deems necessary to meet its objectives.

Operating Principles

The Working Group's activity will be based on the following principles:

• When a lead representative wishes to propose that a representative of another body attend one meeting or become a member of the LCG, such a proposal shall be made well in advance of the meeting.
  
  
• The agenda will be developed jointly by member countries.
  
  
• When used by the LCG, the word "accreditation" means accreditation to the ISO 17025 standard.
  
  
• The Chairperson will be responsible for ensuring that the action items are recorded, the lead person and time frame identified, and the action items distributed.
  
  
• The agency raising an issue shall lead the discussion.
  
  
• The group should establish priorities jointly.
  
  
• For significant issues, the committee should identify each issue to be resolved, with defined objectives, an outline of the working arrangements, and a time frame for resolution of a given issue.
  
  
• Any structure (e.g., sub-committee, task force, etc.) established to handle a particular issue should be flexible and responsive.
  
  
• Individual participants will brief their respective organizations on the discussions and action items resulting from any meeting.

Language

The meetings and teleconferences shall take place in English and Spanish pertaining to the ensemble of the Working Group membership. French interpretation will be available when required. The host country shall be responsible for ensuring simultaneous interpretation as may be necessary.

With respect to press releases, communiqués, and other such materials, each member country shall be responsible for ensuring appropriate translation for dissemination within their own national boundaries, obtaining necessary approvals and/or clearances within mutually agreeable time frames.

MUCH Working Group -- TERMS OF REFERENCE

Purpose

To consolidate and maintain a formal framework for trilateral cooperation in combating health fraud, so as to protect and promulgate the health and economic well being of citizens of all three nations and to identify appropriate lines of communication to ensure a continual exchange of information on compliance and enforcement activities among the three countries.

Health Fraud Definition

For the purposes of this Working Group, health fraud may include the following:

Objective

To the extent compatible with their laws, enforcement policies, and other important interests, each member country shall

• develop and implement comprehensive collaborative approaches and mechanisms to deal with health fraud;

• share information describing current trends in health fraud and strategies for addressing emerging problems;

• cooperate in the detection of cross-border health fraud;

• inform counterpart agencies as soon as practicable of significant investigations and proceedings involving health fraud occurring or originating in the jurisdiction of each member country;

• consider counterpart agency requests to investigate domestic activities having harmful cross-border effects;

• consider coordinating related enforcement activities with counterpart agencies in appropriate cases;

• coordinate import surveillance activities and share information that would maximize surveillance efforts;

• develop and disseminate joint consumer and business education messages about health fraud;

• seek to promote cooperation among federal, state, provincial and local law enforcement agencies of all three member countries, and as appropriate, seek to include such agencies in cooperative efforts to combat health fraud; and

• develop further strategies to achieve coordinated compliance and enforcement; joint consumer and business education; trilateral communication and information exchanges; and the building of partnerships to combat health fraud.

Membership

The MUCH Working Group shall consist of the following:

• Representatives of the regulatory agencies relevant to the control of health fraud from the three signatory countries;

• Representatives of the regulatory and law enforcement agencies with authority or jurisdiction over health fraud issues; and

• Representatives from other government agencies as deemed appropriate by each member country.

Each country shall identify a lead representative and an alternate representative to the Working Group. These three leads and their alternates shall be individuals with responsibility for implementing or recommending policy changes within their organizations.

Structure

Each country will be assigned the responsibility of chairing the Working Group based on a three-year rotation scheduled identified in Section 6C of the Charter. The designated lead country will chair the meetings and conference calls; report, on behalf of the Working Group, to the Trilateral Steering Committee; and provide secretariat services to the Working Group (refer to Section 6C of the Charter).

Ad hoc committees shall be created or disbanded according to Working Group needs. Ad hoc committee members are to be drawn from the Working Group membership, although
non-members may be asked to contribute on the basis of specific expertise.

Decisional Process

Decisions shall be based upon consensus rather than majority vote.

Meetings Schedule

The Working Group shall conduct its business on a continual basis and shall meet in person two times a year at the Trilateral meetings as stipulated in the Section 9 of the Charter and conduct regular business via e-mails, conference calls or video-teleconference as often as the Working Groups deems necessary to meet its objectives.

Language

The meetings and teleconferences shall take place in English and Spanish pertaining to the ensemble of the Working Group membership. French interpretation will be available when required. The host country shall be responsible for ensuring simultaneous interpretation as may be necessary.

With respect to press releases, communiqués, and other such materials, each member country shall be responsible for ensuring appropriate translation for dissemination within their own national boundaries, obtaining necessary approvals and/or clearances within mutually agreeable time frames.

TRAINING Working Group -- TERMS OF REFERENCE

Purpose

To share existing and future information, to establish a communication strategy between the Training Working Group and the other Working Groups and to assist the Trilateral leadership in identifying training needs of common interest for the three countries of staff who will be engaged in activities related to initiatives of the Trilateral Cooperation.

Objectives

1. To develop or assist in the development and delivery of training intended to further the purpose of the Trilateral Cooperation, in line with its strategic objectives, which are to
   • identify and solve problems;
   • share information;
   • identify emerging issues;
   • share best practices;
   • promote capacity building;
   • develop partnership; and
   • establish harmonized positions on issues.
     
     
2. To organize a pre-trilateral seminar, when requested by the Steering Committee, prior to the mid-year and annual meetings. The pre-trilateral seminar will be managed by the host country.

Membership

The Training Working Group shall consist of the following:

• Representatives of the regulatory agencies relevant to training and educational activities from the three signatory countries; and
• Representatives from other bodies, as deemed appropriate by each member country.

Each country shall identify a lead representative and an alternate representative to the Working Group.

Structure

Each country will be assigned the responsibility of chairing the Working Group based on a three-year rotation scheduled identified in the Section 6C of the Charter. The designated lead country will chair the meetings and conference calls; report, on behalf of the Working Group, to the Trilateral Steering Committee; and provide secretariat services to the Working Group (refer to Section 6C of the Charter). Issues requiring follow-up may be delegated to ad hoc groups.

Decisional Process

Decisions shall be based upon consensus rather than majority vote.

Meetings Schedule

The Working Group shall conduct its business on a continual basis and shall meet in person two times a year at the Trilateral meetings as stipulated in the Section 9 of the Charter and conduct regular business via e-mails, conference calls or video-teleconference as often as the Working Groups deems necessary to meet its objectives.

Operating Procedures

• The Training Working Group will be responsible for developing a communication strategy to communicate training needs issues between the Trilateral Working Groups and the Steering Committee.
  
  
• The Training Working Group will be responsible for developing and sharing with the Steering Committee and each Trilateral Working Group, the training needs request template and process. Evaluation criteria will be developed to assess training needs requests.
  
  
• The Steering Committee will be responsible for assessing, prioritizing, and vetting the submitted training requests. The training should be of common interest to the three countries in order for the Trilateral Cooperation to carry out its purpose and objective.
  
  
• Where there are numerous training needs identified, the Steering Committee will take into consideration the priority/ranking and develop a list of topics and share that plan with the Training Working Group. This plan will include budgetary considerations.
  
  
• A Training Working Group representative will be assigned to a specific Working Group and will participate in conference calls/meetings of that particular group in order to support the Working Group with their training needs identification, if deemed necessary.
  
  
• If within a Trilateral Working Group, a training need is identified, the lead of the Trilateral Working Group will complete and submit the Trilateral Training Request to the Steering Committee. The lead of the Trilateral Workgroup will also advise its Training Working Group representative.
  
  
• The Leadership/Trilateral Working Group will identify an individual or individuals who should be contacted to serve as the technical expert or experts on the training subject.
  
  
• Once receiving specific training from the Steering Committee, a representative or representatives of the Training Working Group will contact/meet with the technical expert or experts to develop a course plan. This course plan will be shared and discussed with the other Training Working Group members to ensure that it meets the needs of the three countries. This plan will include the following:
  1. Topic.
  2. Rationale (why needed).
  3. What is to be accomplished as a result of the course/event (learning objectives).
  4. Who
     
     
     1. Course advisory group (CAG) to plan, develop, and eventually deliver the training;
     2. Intended audience; and
     3. Others needed to deliver training (e.g., studio staff; on-site facilitators).
        
        
  5. When (development and delivery time lines)
  6. How (media to be used to deliver training (e.g., satellite, class room), agenda, learning materials, speakers; publicity and other elements, with the goal of ensuring and maximizing access to the learning).
  7. Where (e.g., site and types of uplink, sites of downlinks, class room locations).
     
     
• Once a plan is developed the Training Working Group will gain concurrence from the Trilateral and Working Group leadership.
  
  
• The Training Working Group will assist other members of CAG in developing and delivering a specific training event.
  
  
• The Training Working Group will develop instruments to evaluate all sessions and courses. Evaluation results and other feedback will be given to CAG members, and to Trilateral and Working Group leadership.

Language

The meetings and teleconferences shall take place in English and Spanish pertaining to the ensemble of the Working Group membership. French interpretation will be available when required. The host country shall be responsible for ensuring simultaneous interpretation as may be necessary.

With respect to press releases, communiqués, and other such materials, each member country shall be responsible for ensuring appropriate translation for dissemination within their own national boundaries, obtaining necessary approvals and/or clearances within mutually agreeable time frames.