Article I. Name and Location
The name of this organization shall be the Regulatory Affairs Professionals Society (hereafter "RAPS" or the "Society"), a nonprofit corporation incorporated in the District of Columbia.
The offices of the Society shall be located in the Washington, DC, metropolitan area and/or in other localities as determined by the Board of Directors.
Article II. Purposes
The purposes of the Society shall be to provide and disseminate educational information; to provide and encourage continuing education to regulatory affairs professionals; to improve the professional competency of regulatory affairs professionals and thereby advance public health. At all times the Society shall be organized and operated exclusively for charitable and educational purposes within the meaning of Section 501(c)(3) of the Internal Revenue Code of 1986 or the corresponding provision of any future United States tax code.
Article III. Membership
Section 1. Qualifications and Conditions
Membership in the Society shall be available to individuals of good character associated with healthcare and related policies, regulations and legislation. Membership is not transferable.
Section 2. Categories of Members
A. VOTING MEMBERS
The following members may hold office, serve on committees and appointed groups, and vote on all matters that require action or approval by the members.
ACTIVE MEMBER—Individual engaged in the regulatory process or in related scientific, clinical or engineering areas involved in the health product life cycle.
LIFE MEMBER—Life membership may be offered to individuals who have offered distinguished, long-term service to RAPS and have been continuous members of RAPS for at least twenty (20) years. Life membership shall be conferred by unanimous vote of the Board of Directors. Life members are exempt from payment of dues.
B. NON-VOTING MEMBERS
The following members are entitled to specific services as designated by the Board of Directors, may serve as an advisor on committees or appointed groups, but can not vote or hold elected office.
STUDENT MEMBERS—Student membership is available to any individual enrolled as a full-time undergraduate or graduate student at an accredited higher education institution. Student members are entitled to reduced dues, with the amount determined by the Board of Directors.
HONORARY MEMBERS—Honorary membership may be conferred to individuals who have made significant contributions to biomedicine, healthcare, regulatory affairs or related areas. Honorary membership is conferred by unanimous vote by the Board of Directors. Honorary members are exempt from payment of dues.
OTHER NON-VOTING MEMBERS—Other non-voting member groups that do not meet any of the aforementioned categories, but have a bona fide interest in the regulatory affairs profession and/or in the health product regulatory process are eligible for membership under this category. The Board of Directors will establish the dues level(s) for this category.
Section 3. Termination of Membership
Any member who resigns or is removed from membership shall forfeit any and all rights and privileges of the Society's membership, including dues and fees already paid. Resignation or removal from membership does not relieve a member from liability for fees accrued and unpaid at the date of resignation or removal
A member may resign from the Society by submitting a written resignation to the Executive Director or Board of Directors. A resignation shall be effective as of the date it is received by the Society unless otherwise specified in the letter
A member will be removed from membership after non-payment of dues, in accordance with policies and procedures developed by the Board of Directors.
A member may be removed from membership by a unanimous vote of the Board of Directors based on conduct contrary to the purposes of the Society. A vote for removal shall only occur after the member has been informed of the complaint and has been given a reasonable opportunity for defense.
Article IV. Organization and Structure
Section 1. Organization
To achieve the purposes of the Society, the Board may, at its discretion, establish organizational units such as boards, councils, commissions, committees and task forces to address special needs and interests of the regulatory affairs profession and members. The Board shall exercise authority over policies, services, programs and budgets of all organizational units.
Section 2. Local Organizations
For the advancement of the profession and members, and to meet the purposes of the Society, the Board of Directors may authorize establishment of local affiliates or chapters. Such local chapters must comply with the terms and conditions prescribed by the Board of Directors.
Section 3. Allied Organizations
To advance the profession and quality of healthcare, the Board of Directors may establish relationships with groups of regulatory affairs professionals formed at the local, regional or national levels. The Board may establish terms and conditions for relating to recognized groups.
Article V. Dues
Section 1. Dues
The Board of Directors shall determine the amount of Society initiation fees, dues and other administrative fees. Changes in dues shall be made only with concurrence of at least three-fourths of the Board of Directors.
Section 2. Delinquency
Any Active or Student member who fails to pay dues within sixty (60) days from the required deadline may be dropped from membership.
Article VI. Membership Meetings
The Society shall hold business meetings at such a time and place as determined by the Board of Directors. At least thirty (30) days' notice shall be given to members prior to each business meeting. One (1) meeting each year shall be designated as an annual meeting at which time results of elections for Officers and Directors and other items presented to the membership for vote are reported.
Article VII. Officers
The Officers of the Society shall be Chairman, President, President-Elect and Secretary/Treasurer. Officers must be Active or Life members in good standing.
Section 2. Election and Terms of Office
The President-Elect is elected annually by the membership. The President shall succeed to the office of Chairman, and the President-Elect shall succeed to the office of President. The Secretary/Treasurer shall hold office for three (3) years, or until a successor is elected and installed. The Officers of the Society shall take office as of January 1 of the year following their election. The Chairman, President and President-Elect shall hold offices for one (1) year, or until their successors are installed.
Section 3. Chairman
The Chairman shall be the chief elected official of the Society and shall preside at all membership, Board of Directors and Executive Committee meetings. The Chairman cannot be re-elected to serve as an Officer or Director of the Society.
Section 4. President
The President of the Society shall assume without election the office of Chairman at the expiration of the term of the incumbent. In the absence of the Chairman, the President will preside at meetings of the membership, Board of Directors or Executive Committee and shall perform other duties, as assigned by the Chairman.
Section 5. President-elect
The President-Elect shall assume without election the office of President at the expiration of the term of the incumbent. The President-Elect shall be responsible for becoming acquainted with the functions of the President and Chairman and shall perform other duties, as assigned by the Chairman. The President-Elect will also serve as the liaison from the Board of Directors to the appointed group assigned responsibility for the annual conference program planning.
Section 6. Secretary/Treasurer
The Secretary/Treasurer shall be responsible for supervising the custody, receipt and disbursement of all funds of the Society and for ensuring that notices of meetings are provided and minutes are maintained.
Section 7. Vacancies
In the case of death, resignation or inability of the Chairman to serve, the President shall fulfill the unexpired term while simultaneously serving as President. In case of a vacancy in the office of President, the President-Elect shall fill the unexpired term of office. If the President-Elect resigns or is unable to complete the term of office, a special nomination and election procedure will be enacted.
If the Secretary/Treasurer is unable to fulfill his/her term of office, a successor will be chosen from among members of the Board of Directors by a three-fourths vote of the Board of Directors. The successor will serve until the next scheduled election.
Article VIII. Board of Directors
Section 1. Powers and Responsibilities
The governing body of the Society shall be the Board of Directors. The Board of Directors shall have supervision, control and direction of the affairs of the Society, its finances, organizational units and appointed groups; shall determine Society policies; and shall actively pursue Society purposes and determine strategic directions. The Board of Directors may adopt policies and procedures to conduct its business, as it deems advisable. The Board of Directors may delegate certain authority and responsibility to the Executive Committee. All Directors shall be active members in good standing.
Section 2. Composition and Terms of office
The Board of Directors shall consist of the Chairman, President, President-Elect, Secretary/Treasurer, at least six (6) elected Directors and the Executive Director, who serves in an ex-officio, nonvoting capacity. The number of Directors may be increased by a three-fourths vote of the Board of Directors. Election and terms of office of Officers are described under Article VII. Each Director shall serve a three (3)-year term, which begins on January 1 in the year after his/her election. A Director cannot serve more than two (2) consecutive terms as Director but may serve as an Officer.
Section 3. Nominations
The Nominating Committee, acting in accordance with Article IX, Section 3, shall present one nominee for each seat on the Board of Directors which is about to expire.
Section 4. Vacancies
In the case of death, resignation or inability of any Director to fulfill his/her term of service, the unexpired term will be filled by action of three-fourths of all members of the Board of Directors.
Section 5. Prohibitions
No Officer or Director shall directly or indirectly receive salary, compensation or emolument of any kind, unless expressly approved by at least three-fourths of the Board of Directors. No member of the Board of Directors shall be interested in any contract relating to operations conducted by the Society or in any contract for supplies, equipment or furnishings unless expressly approved by three-fourths of the Board of Directors.
Section 6. Removal
The Board of Directors may, at its discretion, remove an Officer or Director for good cause by a three-fourths vote of the Board of Directors.
Section 7. Meeting
Meetings of the Board of Directors shall be held at a time and place as the Board may determine, or upon the call of the Chairman. Meetings may be conducted by mail, telephone or electronically unless a member of the Board of Directors objects in writing to the Chairman.
Section 8. Quorum
A majority of voting members of the Board of Directors shall constitute a quorum for the transaction of business.
Section 9. Voting
With the exception of the Chairman, each Officer and Director shall be entitled to one (1) vote. The Chairman shall vote to break a tie vote. Unless otherwise prescribed, a majority of members of the Board of Directors present and voting shall determine action.
Article IX. Voting
Every Active and Life member of the Society shall be entitled to cast one (1) vote on any matter voted on by the membership and/or in any election of an Officer or Director. Votes may be cast via postal mail, telefacsimile, electronic mail, or other modes of electronic communication permitted by applicable law.
Section 2 Annual and Special Meetings
At any business or special meeting, each Active and Life member in good standing is entitled to one (1) vote. Unless otherwise specified by these Bylaws, a majority vote by those attending the meeting shall determine action.
Section 3. Other Voting Procedures
Proposals for actions other than the election of Officers and/or directors also may be presented to the membership for vote Such proposals shall first be approved by the Board of Directors, unless a proposal is endorsed by three (3) percent of Active and Life members. Unless specifically provided by these Bylaws, a majority vote by those voting shall govern provided that not less than ten (10) percent of voting members participate.
Section 4. Proxy Voting
There shall be no proxy voting.
Article X. Committees
The Standing Committees of the Society shall be the Executive Committee, Nominating Committee, and Finance Committee. The Board of Directors may establish other committees, task forces and appointed Bodies to pursue the purposes of the Society. All committees and appointed bodies shall be accountable to The Board of Directors, and the Board shall exercise authority over procedures, services, programs and budgets.
Section 2. Executive Committee
The Executive Committee shall consist of the Chairman, President, President-Elect, Secretary/Treasurer and the Executive Director in an ex-officio, nonvoting capacity. The Executive Committee may act for the Board of Directors pursuant to authority delegated by the Board of Directors. A majority of the Executive Committee shall constitute a quorum at any duly called meeting. A meeting may be called at any time by the Chairman or by two (2) members of the Executive Committee as the business of the Society may require.
Section 3. Nominating Committee
The Chairman, with approval of the Board of Directors, shall name a Nominating Committee consisting of seven (7) members in good standing, including the immediate past Chairman of the Board of Directors. The Nominating Committee shall use its best efforts to select one (1) qualified candidate from the Society's membership for each Officer and Director position to be filled.
At least ninety (90) days prior to the date designated by the Board of Directors for the annual meeting, the Nominating Committee shall present to the membership its slate of qualified candidates. Additional nominations for any Officer or Director position shall be made by written petition, specifying a qualified candidate's name and position sought and bearing the name, contact information and signature of at least one hundred (100) Active and Life members in good standing. Such petitions must be submitted to the Nominating Committee not more than thirty (30) days after the Nominating Committee has presented its slate of candidates to the membership.
In the event of one or more nominations by petition, a written ballot shall be prepared by the Nominating Committee and distributed to all Active and Life members in good standing. Such ballot shall be distributed not less than forty-five (45) days prior to the date designated by the Board of Directors for the annual meeting. The ballot shall indicate the nominees recommended by the Nominating Committee and those recommended by petition. The Nominating Committee will conduct an election in which each Active member and each Life member shall be entitled to one (1) vote for each Officer and Director position to be filled. The candidate receiving the highest number of votes for each position shall be elected.
If no nominations are made by petition, the Secretary/Treasurer shall cast a unanimous ballot for the candidates presented by the Nominating Committee and no further balloting will be required. Results of the election will be announced no later than the next subsequent annual meeting.
Section 4. Finance Committee
The Finance Committee shall provide input and guidance to the Board of Directors on financial processes and oversight, budget review and monitoring, and investments. The Committee shall be made up of those members appointed by the Chairman. The Committee shall be chaired by the Treasurer and reports to the Board of Directors.
Section 5. Regulatory Affairs Certification Board
The Regulatory Affairs Certification Board (RACB) shall be responsible for developing policies and procedures for the Regulatory Affairs Certification Program and for supervising all activities related to certification. The RACB may delegate work related to the certification examination(s) or other key functions to subcommittees.
Article XI. Finances
Section 1. Fiscal Year
The Board of Directors shall determine the fiscal year of the Society.
Section 2. Budget
The Board of Directors shall adopt an annual budget in advance of the fiscal year. The budget will be reviewed by the Finance Committee prior to Board review and adoption. The Finance Committee and Board may consider revisions to the budget during the fiscal year. All such revisions must be approved by the Board before they may become effective.
Section 3. Audits
The accounts of the Society shall be audited annually by a certified public accountant, who shall be approved by the Board of Directors, and who shall provide a written report and certified audit to the Board of Directors.
Article XII. Amendments
Amendments to the Bylaws may be proposed by resolution of the Board of Directors or by petition submitted by three (3) percent of the Active and Life membership. Proposed changes to the Bylaws from the membership must be submitted to the Board of Directors at least one hundred eighty (180) days before the date designated by the Board of Directors for the annual business meeting.
The Board of Directors shall present proposals to amend the Bylaws to the membership with or without endorsement at least forty-five (45) days before the Society's annual meeting. Voting shall be conducted following provisions of Article IX.
Adoption of any amendment shall require two-thirds of votes cast.
Unless otherwise stated, amendments to the Bylaws shall become effective at the beginning of the next fiscal year.
Article XIII. Staff and General Counsel
The Board of Directors is empowered to retain such staff and legal counsel as may be necessary to carry out the functions of the Society.
The chief executive staff member shall be given the title of Executive Director and shall assume such duties as assigned by the Chairman and/or Executive Committee, including those of assisting the Secretary/Treasurer.
The General Counsel of the Society shall attend to and act on behalf of the Society in matters requiring legal services.
Article XIV. Indemnification
The Society shall indemnify every Officer, Director and staff member in connection with expenses, liability or the settlement of any claim, action, suit or proceeding in which they are parties by reason of having been such an Officer, Director or staff member.
Article XV. Dissolution
In the event of dissolution or final liquidation of the Society, its remaining net assets shall be distributed to one (1) or more nonprofit organizations having purposes and activities similar to those of the Society in the in the manner set forth in the Society's Articles of Incorporation.
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