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Bulgarian Forum of Experts in Regulatory Affairs (BUFER)

(draft provisional)
Terms of Reference

Article 1
Designation of BUFER

The 'Bulgarian Forum of Experts in Regulatory Affairs' is a not-for-profit organisation dedicated to the improvement of the regulatory environment for clinical research in Bulgaria through information exchange, discussion, and education.
The organisation has adopted the acronym 'BUFER'.

Article 2
Emblem of BUFER

The logo of BUFER shall be nominated by the Steering Committee and approved by the first General Assembly.

Article 3
Seat of BUFER

The official location of BUFER is the office the Chairperson of BUFER.

Article 4

The objectives of BUFER are:
1. To keep up-to-date with EU regulatory policies and procedures
2. To create and maintain an effective forum for the exchange of information between pharmaceutical companies and CROs at one hand and the responsible Regulatory authorities on the other
3. To promote the national implementation of progressive regulatory programs and standards in order to achieve highest possible standard of clinical research in Bulgaria
4. To approximate the conditions and the regulatory environment for conducting clinical trials in Bulgaria to the world standards
5. To assure the protection of the rights of study subjects

Article 5

Membership of BUFER comprises:

1. Ordinary Members who are, or used to be experts from the Bulgarian Drug Agency, Bulgarian Ministry of Health and the Regulatory Affairs Departments of pharmaceutical companies and CROs.
2. Honorary Members are those invited by the Steering Committee to be an Honorary Member.

Article 6
Membership Responsibilities

The rights and obligations of members are the following:
1. Ordinary members have rights and obligations as follows:
   a) Render support to activities of BUFER.
   b) To be elected or selected as a Steering Committee member of BUFER.
   c) Participate in activities that have been set up by BUFER.
   d) Propose opinions to the Steering Committee.
   e) Request for a special General Assembly of BUFER to evaluate and change rules and regulations of BUFER.
2. Honorary members have rights and obligations as follows:
   a) Render support to activities of BUFER.
   b) To be invited as a consultant of BUFER.
   c) Participate in activities initiated by BUFER.
   d) Give advice and consultation to BUFER.

Article 7
Membership Term and Fee

Membership is for life. It is voluntary and free of charge.

Article 8
Membership Termination

Membership ends by:
1. Death,
2. Resignation,
3. Withdrawal by more than two-thirds majority vote of the whole Steering Committee.

Article 9
Composition and Appointment of the Steering Committee

The Steering Committee comprises the following six officers:
• Chairperson
• Co-Chairperson
• Secretary
• Ethics Officer
• GCP Officer

The officers are elected by the General Assembly.

In the event of vacancy of any position before the term expires, the Steering Committee shall appoint a new member to fill the vacancy to serve until the end of the original term.

Article 10
Responsibilities of the Steering Committee

The Steering Committee is authorised to assume the following responsibilities:
1. Undertaking the objectives of BUFER;
2. Appointing sub-committees or working teams as deemed necessary;
3. Ensuring to arrange a General Assembly meeting at least once a year to report past activities, financial statements, and future plans.

Article 11
Term of Office for the Steering Committee

The term of office for members of the Steering Committee is three years.

Article 12
Termination of Office for a Steering Committee Member

A Steering Committee member’s office can be terminated upon:
1. Death;
2. End of term;
3. Resignation;
4. Disqualification of ordinary membership;
5. Individual or all Steering Committee members can be removed by the vote of more than two-thirds of members present at the General Assembly provided that the proposal for removal has been included on the agenda in advance;
6. At least ten ordinary members must request the proposal for removal to be included in the agenda ten days prior to the meeting of the General Assembly.

Article 13
Responsibilities of the Steering Committee Offices

The Chairperson is responsible for undertaking all duties under the objectives of BUFER.
The Co-Chairperson is responsible for the Chairperson’s responsibility in his/her absence or when he/she is unable to work; and for duties designated by chairperson.
The Secretary is responsible for
1. Preparing and keeping membership records,
2. Preparing meetings,
3. Recording the minutes of meetings,
4. Coordinating with other organisations,
5. Other duties as designated by the Chairperson.

The Ethics Officer is responsible for ensuring the ethical quality of BUFER as an organisation and the integration of national and international issues in health research ethics into the activities of BUFER.

The Good Clinical Practice Officer is responsible for the developing GCP practices and awareness within BUFER as well as for integrating national and international GCP frameworks into GCP practice in Bulgaria.

Article 14
Steering Committee Meetings

1. The Steering Committee must meet at least twice times a year.
2. The minimum number of Steering Committee members must be at least four to meet the quorum requirement.
3. The Steering Committee attempts to reach its decisions by consensus. When this is not possible, a vote of at least 51% of those present is required for a decision. Members holding a minority view may request to record a dissenting opinion.

Article 15
The General Assembly

1. The Steering Committee must arrange the General Assembly at least once a year.
2. At least one-third of all ordinary members agreement is required to request a special General Assembly. The Steering Committee must arrange the meeting within 45 days upon receiving such a written request.
3. The General Assembly requires at least one-third or not less than twenty members, to meet the quorum requirement

Article 16
Finances of BUFER

1. The Treasurer is responsible for keeping all funds of BUFER that are under the supervision of the Committee.
2. Funds of BUFER must be deposited in the bank or savings co-operative in the institute where the Treasurer is working.
3. The Treasurer can keep no more than 1000 Leva petty cash, unless otherwise deemed necessary with approval of the Chairperson, on a case-by-case basis.
4. The Treasurer must prepare an accurate account, including
   a) Receivable and payable accounts of BUFER.
   b) Assets and liabilities accounts of BUFER.
5. All payments of BUFER must be the Treasurer and one other person designated by the Steering Committee.
6. Sources of income of BUFER are from:
   a) National or international institutions agreed to by the Steering Committee.
   b) Other methods (e.g., activities organised by BUFER).

Article 17
Dissolving BUFER

1. BUFER shall be dissolved through a resolution of the General Assembly attained by not less than two-thirds vote of all members.
2. When dissolved, all assets of BUFER shall be given to the public organisations according to approval of the Steering Committee.

Article 18
Transitory Provisions

A Temporary Steering Committee will be elected at the General Assembly of the Association. This Committee will have responsibility to review the Terms of Reference and carry out a nation-wide consultation prior to the next General Assembly in 2005 where the final Terms of Reference will be presented for approval and the first ‘Steering Committee’ may be elected.

Temporary Steering Committee Members

Ethics Officer
GCP Officer


© 2002 AGCPCRD