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I. NAME, LOCATION, OBJECTIVES

Article 1
The International Association for Biologicals (hereafter called "The Association") is a non-profit making Association governed by Articles 60 - 79 of the Swiss Civil Code and the present Statutes.

Article 2
The Association acts as a Commission of Microbiological Standardization of the International Union of Microbiological Societies.

Article 3
The objectives of the Association are to promote research, development, characterization, standardization, quality control, improvements in production technology and clinical assessment of medicinal products derived from biological sources and which are used to solve human and veterinary public health problems. Such sources include animals, organs, tissues and cells, both natural and genetically modified. Examples of biological products include vaccines, blood and blood derivatives, cytokines and growth factors. In addition, the Association is prepared to offer assistance to international organizations active in this field.

The Association, through its conferences and publications, facilitates the establishment of international reference materials and the formulation of international guidance documents for biological substances used in human and veterinary medicine.

Article 4
In particular, the Association shall be concerned with the following:
  • to serve as a platform for discussion and the development of consensus positions on contemporary issues related to biologicals;
  • to organize scientific conferences, and to publish reports of such meetings;
  • to make known to the membership information of general interest concerning the characterization, standardization, quality control, and where applicable, the production and clinical assessment of biological products;
  • to promote uniform methods for establishing the international quality control of biological products;
  • to promote the knowledge and use of international reference materials established by WHO;
  • to encourage research in connection with the characterization, standardization, quality control, production, and clinical use of biological products.

II. MEMBERSHIP

Article 5
Members shall be persons interested in research, characterization, standardization, quality control, production, or clinical assessment and the marketing authorization of biological products.

The Association shall be composed of the following classes of members:
  • individual members (individuals who are actively working in the field and who pay dues),
  • emeritus members (individuals who have been members for at least ten (10) years and who have retired),
  • honorary members (individuals who have been elected to membership by the Board in special recognition of their contributions to the field of biologicals),
  • student members (individuals who are pursuing a degree in science or medicine and who pay dues),
  • developing country members (individuals who reside and work in developing countries as defined by the United Nations).
Article 6
Applications for membership shall be addressed to the Geneva secretariat of the Association which shall refer such applications to the Board for approval. The decision of the Board shall be made by a two-thirds (2/3) majority vote of the Board members present and voting.

If membership is refused by the Board, the applicant may appeal to the General Assembly, which shall decide by a two-thirds (2/3) majority of those present and voting by secret ballot.

Article 7
Membership shall be terminated by:
  • resignation;
  • failure to pay dues to the Association for two (2) consecutive years. The Board shall approve such terminations at the first meeting of each year;
  • expulsion for such reasons as the Board shall determine to be in the interest of the Association. If a member is expelled by the Board, the member may appeal to the General Assembly, which shall decide by a two-thirds (2/3) majority of those present and voting by secret ballot.

III. ORGANIZATION

Article 8
The Association shall include the following bodies:
  • the General Assembly
  • the Board
  • the Executive Committee
  • other committees that the Board determines are appropriate

IV. THE GENERAL ASSEMBLY

Article 9
The supreme authority of the Association is vested in the General Assembly which shall be constituted from the membership. The General Assembly covers and controls all of the other organs of the Association and assumes all tasks not assigned by the Statutes to the other organs. The General Assembly reserves the right to revoke the organs of the Association and to supervise the activities of the organs. In particular, the General Assembly shall not delegate to the Board or to another organ the responsibility to approve or reject the accounting reports, and to dismiss the auditors.

Each member of the Association shall be entitled to one vote on administrative, financial and legal matters. Scientific and technical matters shall not be voted upon.

Article 10
The General Assembly shall meet every two (2) years on the occasion of a scientific conference sponsored by the Association.

The Secretary shall notify the membership at least three (3) months in advance of the date, hour, and place where the General Assembly will be held. The proposed agenda shall accompany such notification.

Each member may, within a period of one (1) month, ask for an amendment or amendments to the agenda. The final agenda, including any amendments to the proposed agenda, shall be sent to the membership one (1) month before the General Assembly. The General Assembly shall not take any decisions on items not included on the agenda.

Article 11
The General Assembly is validly constituted if a quorum of at least five percent (5%) of the members of the Association is present or represented by proxy.

If a quorum is not present, a second Assembly shall be announced within a period of one (1) month with the same agenda. This Assembly must be held not earlier than one (1) month and not later than two (2) months after the announcement has been sent to the membership.

This second Assembly is validly constituted whatever the number of members present or represented by proxy.

Article 12
The General Assembly shall be presided over by the President, or in his absence, by one (1) of the Vice Presidents.

Article 13
The following items shall be presented to the General Assembly for approval:
  • the Minutes of the last General Assembly
  • the Report of the Secretary
  • the Report of the Vice President for Human Biologicals
  • the Report of the Vice President for Veterinary Biologicals
  • the Reports of Committee Chairmen
  • the Report of the Treasurer
  • the Report of the Auditors
  • the Budget.
The General Assembly shall:
  • approve the annual membership dues
  • discuss the other items on the agenda
  • elect the Board members
Article 14
All decisions at the General Assembly shall be reached by a simple majority vote of the members present by a show of hands. Two (2) members of the Board or five (5) members of the General Assembly may, however, demand a secret ballot.

Article 6, paragraph 2; Article 7, paragraph C; and Article 27 paragraph 2 are reserved.

Voting by proxy shall be permitted. A member voting by proxy shall give her/his representative, who shall be a member of the Association, at the General Assembly an authorization to vote on her/his behalf. The Secretary shall be notified in writing of such authorization prior to the General Assembly.

A vote by proxy is equivalent to a vote by a member present at the General Assembly.


V. The Board of Directors (Board)

Article 15
The Association shall be administered by a Board of 15 members, elected for a period of six (6) years. A Board member may serve for no more than two (2) consecutive terms of six (6) years each. Five Board members shall be elected every two (2) years, two (2) of whom shall be from the human biologicals field, two (2) from the veterinary biologicals field, and one (1) at-large member may be from either field.

A member of the Association in good standing may be nominated as a candidate for election to the Board by five (5) Association members or two (2) members of the Board.

The election of the members of the Board shall be carried out by postal vote. A postal vote is valid if a quorum of at least five percent (5%) of the members of the Association submits a ballot. If a quorum of at least five percent (5%) of the member ship does not submit a postal ballot, a second postal vote shall be announced. The vote must not be earlier than one (1) month and not later than two (2) months after the announcement has been sent to the membership. A paper ballot shall be sent to each member by the Secretary or the President. In the event of a vacancy occurring on the Board during its term of office, a member shall be temporarily co-opted by the Board until the next General Assembly.

The Board is responsible for ensuring that the Association's goals are respected and that all its activities are undertaken in a satisfactory manner. It is also responsible for ensuring that the present Statutes are properly applied and that the Association's assets, including its income, are adequately employed.

The Board shall review the annual accounts of the Association and submit these every two (2) years to the General Assembly for ratification.

The Board decides upon the admission, termination and expulsion of members in accordance with the present Statutes.

Article 16
The Board shall meet at least twice a year and at such other times as the activities of the Association require.

The Board shall in principle be convened by the President with reasonable advance notice. It shall also be convened by the Secretary upon the request of either three (3) members of the Board or of thirty (30) members of the Association.

The Board is validly constituted if a quorum of at least eight (8) members of the Board is present or represented by proxy. A member voting by proxy shall give her/his representative, who shall be a member of the Board, an authorization to vote on her/his behalf. The Secretary shall be notified in writing of such authorization prior to the Board meeting.

The President shall have the deciding vote if the number of votes cast is equal. The Board may consult absent members of the Board. Minutes of such correspondence shall be recorded.

Article 17
The Board shall elect the following Officers from among its members, each for a term of two (2) years:
  • The President
  • The Vice President for Human Biologicals
  • The Vice President for Veterinary Biologicals
  • The Secretary
  • The Treasurer
The President and Vice Presidents may serve in the same office for no more than three (3) consecutive terms of two (2) years each. The other Officers are not limited in the number of terms they can serve.

The Officers may be assisted by advisors, selected for their specific competence. Subject to approval by the President, such advisors may be invited to the meetings of the Board.

Article 18
The Board shall delegate the daily planning and implementation of the Association's various activities to the following bodies, which shall act in accordance with the functions attributed to them by the present Statutes: the Executive Committee and other committees that may be established.

Article 19
In order to ensure the ongoing administrative functions of the Association, to disseminate information and to coordinate the Association's activities, the Board shall maintain a permanent secretariat in Geneva.


VI. THE EXECUTIVE COMMITTEE

Article 20
The Executive Committee is constituted by the President, the Secretary, the two (2) Vice Presidents, and the Treasurer. The Executive Committee shall be presided over by the President.

The Executive Committee shall approve the programme of activities and coordinate the activities of the different committees that may be established by the Board.

The Executive Committee shall also be authorized to make decisions with regard to the engagement of permanent staff for the secretariat in Geneva as well as concerning the day to day running of the secretariat, within the limits of the approved budget.

The Executive Committee can communicate and make decisions at its meetings or outside such meetings. However, all decisions made by the Executive Committee must be unanimous. The Executive Committee shall meet whenever requested by the President with reasonable advance notice.

A summary of the Executive Committee's activities will be contained in the general report made to the General Assembly by the Secretary.

The Executive Committee's activities as well as those of its members will be performed with the material support of the secretariat in Geneva, which shall be managed by the Secretary and the Treasurer.


VII. OTHER COMMITTEES

Article 21
Each committee shall be under the responsibility of a chairman appointed by the Board. At the start of each calendar year, the chairman shall submit to the Executive Committee for approval an activity report for the past year, an action plan for the new year, and a budget for the new year. Each committee shall have as many members as the chairman deems necessary and appoints, with the agreement of the Executive Committee. The Board reserves the right to dismiss a committee chairman or an entire committee, if, in the view of the Board, the chairman or the committee fails to meet its responsibilities.


VIII. THE PRESIDENT, VICE PRESIDENTS, SECRETARY, AND TREASURER

Article 22
The President shall preside over the meetings of the General Assembly, the Board and the Executive Committee. She/he shall represent the Association in negotiations with external bodies, but may delegate those responsibilities to other appropriate Officers of the Association when it is in the interest of the Association to do so.

The Vice-Presidents shall assist the President in the execution of her/his duties, and one of the two Vice-Presidents shall preside at meetings of the Association, including the Board and Executive Committee meetings, in her/his absence.

The Secretary shall report to the General Assembly regarding the administration of the Association. She/he shall also be responsible for recording the Minutes of meetings of the General Assembly, the Board and the Executive Committee.

The Treasurer shall be responsible for the financial administration of the Association including the preparation of the budget and the statement of audited accounts for presentation at the General Assembly. In addition, the Treasurer shall be responsible for managing the secretariat in Geneva with the assistance of the Secretary.


IX. AUDITORS

Article 23
Two (2) auditors shall be appointed by the Executive Committee and report to the General Assembly. Only the General Assembly may dismiss the auditors.


X. COMMITMENT BY SIGNATURE

Article 24
The signature of two (2) of the following: the President, the Secretary or the Treasurer, shall constitute a valid and binding commitment of the Association towards third parties.


XI. SOURCES OF INCOME

Article 25
The Association's income shall be derived from:
  • members' dues and donations
  • grants which it may receive
  • gifts or legacies which it may receive
  • scientific conferences and publications
  • other sources.

XII. CHANGES TO THE STATUTES AND DISSOLUTION OF THE ASSOCIATION

Article 26
Proposals for changes to the Statutes shall be submitted to the General Assembly by the Board. At least five (5) members of the Association shall be required to petition the Board to submit such proposals to the General Assembly. The text of such proposed changes shall be sent to the Secretary at least two (2) months before the General Assembly.

Changes to the Statutes must be approved by a two-thirds (2/3) majority of the members present and voting at the General Assembly.

Article 27
The Association may propose its dissolution by notice in the Agenda of the General Assembly. Such decision shall be taken by the General Assembly voting by secret ballot. The result of the vote shall be communicated to all members of the Association in writing.

After all liabilities have been met, the balance of monies remaining shall be credited to one or more scientific organizations concerned with medical biology. The choice of such a body or bodies shall be made by the General Assembly, to which the Board shall submit its proposals in this connection.


XIII. MISCELLANEOUS

Article 28
The methods by which these Articles are to be implemented may be stipulated in regulations, whose text shall be drafted by the Board and submitted to the General Assembly for approval.

Article 29
The President and the Secretary, both being present at the General Assembly, shall each be required to acknowledge by signature the authenticity of the present Statutes and any amendments to the Statutes as may be adopted by the General Assembly.

Article 30
The first Statutes of the Association were adopted by the General Assembly meeting on 20th September, 1959, in Tel Aviv. These revised statutes were accepted by the General Assembly meeting on 3 June 2002, in Lyon.

Secretary
(signed) Daniel Gaudry (France)

President
(signed) John Petricciani (USA)

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Copyright IABS
International Association
for Biologicals 2007

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