Bylaws of the Regulatory Affairs Professionals Society

Article I. Name and Location

Section 1. Name and Organizations

The name of this organization shall be the Regulatory Affairs Professionals Society (hereafter “RAPS”), a nonprofit corporation incorporated in the District of Columbia.

Section 2. Offices

The offices of RAPS 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 RAPS are as set forth in RAPS’ Articles of Incorporation. At all times RAPS 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 (the “Code”).

Article III. Membership

Section 1. Qualifications and Conditions

Membership in RAPS is available to individuals interested in furthering the purposes of RAPS, associated with healthcare and related policies, regulations and legislation, and meeting any other membership qualifications set forth in these Bylaws as established by the RAPS Board of Directors. Individuals seeking membership, and fulfilling the stated qualifications of an applicable class of membership, will be accepted upon the submission, receipt and processing of any required application materials and fees. Membership is not transferable.

Section 2. Categories of Members

A. VOTING MEMBERS

The following members are eligible to hold office, and serve on and lead committees, and will be entitled to cast one (1) vote on all matters that require action or approval by the members. The Active Members and Life Members shall be referred to collectively throughout these Bylaws as the “Voting Members.”

ACTIVE MEMBER—Active membership is available to individuals engaged in the regulatory process or in related scientific, clinical or engineering areas involved in the health product lifecycle..

LIFE MEMBER—Life membership may be made available to individuals who have offered distinguished, long-term service to RAPS, are retired and have been continuous members of RAPS for at least twenty (20) years. Life membership is 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 be eligible to serve as an advisor on committees or appointed groups, but cannot vote or hold elected office. The Student Members and Other Non-Voting Members shall be referred to collectively throughout these Bylaws as the “Non-Voting Members.”

    i. 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.

    ii. 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.

C. OTHER CATEGORIES OF MEMBERSHIP

The Board of Directors may establish additional categories of voting or non-voting membership, with such rights and obligations as determined by the Board of Directors.

Section 3. Resignation or Termination of Membership

Any member who resigns or is otherwise removed from membership in the manner set forth herein will forfeit any and all rights and privileges of RAPS’ membership, including dues and fees already paid. Resignation or removal from membership does not relieve a member from any obligations incurred or commitments made prior to the date of resignation or termination of membership.

A member may resign from RAPS 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 RAPS unless otherwise specified in the letter.

A member will be removed from membership after non-payment of dues for sixty (60) days following the deadline for submission of dues, in accordance with policies and procedures developed by the Board of Directors, provided the member is first provided with notice of non-payment and an opportunity to submit the required dues.

A member may be removed from membership by a vote of a majority of the Board of Directors then in office, based on conduct contrary to the purposes of the RAPS and in violation of any applicable RAPS policies. A vote for removal shall occur only after the member is informed of the complaint and is given a reasonable opportunity for defense and to be heard before the Board of Directors, either in writing or in person.

Section 4. Dues

The Board of Directors will determine the amount of dues and other fees required to be paid by each membership class. Changes in dues will be made only upon the approval of two-thirds of the Board of Directors present and voting at a meeting at which a quorum is established.

Article IV. Membership Meetings

Section 1. Annual and Business Meetings

RAPS shall hold meetings of the membership at a time and place as determined by the Board of Directors. At least thirty (30) days' notice of the time, date and location of the meeting will be given to the Voting Members. One (1) meeting each year shall be designated as an annual meeting at which time, if applicable, the Chairman may report on the accomplishments from the prior year and other actions may be taken. Voting Members and the Board of Directors can request topics to be put on the agenda. Voting members either need 10 voting members to support their agenda topic or the acceptance of this agenda point by the Board of Directors.

Section 2. Special Meetings

Special meetings of the Voting Members may be called as permitted by the District of Columbia Nonprofit Corporation Act (the “Act”).

Section 3. Meetings by Electronic Communications

Any meeting of members does not need to be held at a geographic location if the meeting is held by means of the Internet or other electronic communication technology in a fashion pursuant to which the members have the opportunity to read or hear the proceedings substantially concurrently with their occurrence, vote on matters submitted to the members, pose questions and make comments.

Section 4. Quorum

Ten percent (10%) of the Voting Members shall constitute a quorum for the transaction of business at any meeting of the Voting Members, provided, that if less than a quorum of the Voting Members are present at said meeting, a majority of the Voting Members present may adjourn the meeting without further notice.

Section 5. Voting By Ballot

Any action that may be taken at any annual, business or special meeting of the Voting Members may be taken without a meeting if RAPS delivers a ballot to every Voting Member. A ballot shall set forth each proposed action; provide an opportunity to vote for, or withhold a vote for, each candidate for election as a director (but only if such a vote is necessary, as provided for in Article VI, Section 3 of these Bylaws); and provide an opportunity to vote for or against each proposed action. Approval by ballot shall be valid only when the number of votes cast by ballot equals or exceeds the quorum required to be present at a meeting authorizing the action, and the number of approvals equals or exceeds the number of votes that would be required to approve the matter at a meeting at which the total number of votes cast was the same as the number of votes cast by ballot. All solicitations for votes by ballot shall: indicate the number of responses needed to meet the quorum requirements; state the percentage of approvals necessary to approve each matter other than election of directors; and specify the time by which the ballot must be received by RAPS in order to be counted. Ballots may be submitted by electronic means.

Section 6. Proxy Voting

Voting Members are not permitted to vote by proxy.

Article V. Organization and Structure

Section 1. Organizational Units

To achieve the purposes of RAPS, the Board may, at its discretion, establish organizational units such as councils, commissions, committees and task forces to address special needs and interests of the regulatory affairs profession and RAPS members. The Board will establish policies to govern, and will exercise authority over, the services, programs and budgets of all organizational units.

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Section 2. Local Organizations

For the advancement of the mission and purposes of RAPS, the Board of Directors may authorize the establishment of local affiliates or chapters. Such local affiliates or chapters must comply with the terms and conditions prescribed by the Board of Directors.

Section 3. Allied Organizations

To advance the mission and purposes of RAPS, the Board of Directors may establish relationships with groups of regulatory affairs professionals formed at local, regional or national levels. The Board will establish terms and conditions for establishing such relationships.

Article VI. Board of Directors

Section 1. Power and Responsibilities

    i. The Board of Directors is responsible for governing RAPS; establishing the directions of RAPS; setting policy and strategy; reviewing and monitoring plans for achieving the Board’s objectives; and approval and oversight of the RAPS budget.

    ii. The Board of Directors may adopt policies and procedures to conduct its business, as it deems advisable.

    iii. The Board of Directors may delegate certain authority and responsibility to the Executive Committee as permitted by the Act.

    iv. The Board of Directors is accountable to the global membership.

Section 2. Composition and Terms of Office

The Board of Directors shall consist of the Chairman, President, President-Elect, Treasurer, at least six (6) elected Directors, and the Executive Director, who serves in an ex-officio, non-voting capacity. All Directors must be Active Members in good standing. The number of Directors may be increased by a three-fourths vote of the Board of Directors present and voting at a meeting at which a quorum is established. Election and terms of office of Officers are as set forth in this Article VI and in Article VII. Each Director shall serve a three (3)-year term, which begins on 1 January in the year following his/her election; provided, however, that Directors will serve until their successors have been duly elected and have qualified. A Director cannot serve more than two (2) consecutive terms as Director but may continue to serve on the Board if elected to serve as an Officer.

Section 3. Nomination and Election of Board

    i. NOMINATIONS: The Nominating Committee will determine the process for soliciting and reviewing nominations for each open Officer and Director position and will communicate this to the RAPS membership each year prior to opening the nominiations process. Any Voting Member will be eligible to submit nominations materials on his/her behalf or on behalf of a colleague who is a Voting Member. The Nominating Committee shall use its best efforts to select at least one (1) qualified candidate from among the Active Members for each Officer and Director position to be filled at the upcoming election.

    ii. DEVELOPMENT OF SLATE: The Nominating Committee will consider all applications from qualified candidates. and shall use its best efforts to select at least one (1) qualified candidate from among the nominees for each Officer and Director position to be filled. The Nominating Committee then will present its slate of qualified candidates to the Voting Members at least ninety (90) days prior to the date designated by the Board of Directors for the annual meeting. Additional nominations of qualified candidates for any Officer or Director position may be made by a petition signed by no fewer then fifty (50) Vorting Members in good standing. Such petitions must specifiy the qualified candidate’s name and the position sought; such petitions along with other required background materials must be submitted to the Nominating Committee not more than thirty (30) days after the Nominating Committee has presented its slate of candidates. If no petitions are received during the thirty (30) day period, the slate proposed by the Nominating Committee will be confirmed.

    iii. ELECTION: In the event that there is more than one (1) candidate for one (1) or more Officer and/or Director positions (such as due to the submission of a valid petition), a written ballot shall be prepared by the Nominating Committee and approved by the Board of Directors, and shall comply with the requirements set forth in Article IV, Section 6. The ballot will be distributed to all Voting Members in good standing 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. Every Voting 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. Results of the election will be announced no later than the annual meeting.

    Section 4. Vacancies

    In the case of death, resignation or inability of any Director to fulfill his/her term of service, the Executive Committee may recommend to the remaining members of the Board of Directors the names of qualified individuals to fill the vacancy for the unexpired term. The vacancy will be filled by action of a majority of the members of the Board of Directors remaining in office.

    Section 5. Compensation

    No Director shall directly or indirectly receive salary, compensation or emolument of any kind for services rendered to RAPS, except that Directors may be reimbursed for reasonable expenses incurred in the performance of their duties to RAPS. Nothing herein shall be construed to preclude any Director from serving RAPS in a capacity other than that of Director and receiving reasonable compensation for such service, provided RAPS adheres to its Conflict of Interest and any other policy in approving such arrangement. Any such service must be made transparent to all Directors.

    Section 6. Removal

    Directors may be removed in the manner provided for in the Act.

    Article VII. Officers

    Section 1. Officers

    The Officers of the Society shall be Chairman, President, President-Elect and Treasurer, each to have such duties and authority as are specified in these Bylaws or as prescribed by the Board. Officers must be Active or Life Members in good standing.

    Section 2. Election and Terms of Office

    The President-Elect is selected annually in the manner set forth in Article VI, and the Treasurer is selected every three years in the manner set forth in Article VI. The Chairman, President and President-Elect shall hold offices for one (1) year, or until their successors are installed. The President-Elect shall succeed to the office of President, and the President shall succeed to the office of Chairman. The Treasurer shall hold office for three (3) years, or until a successor is elected and installed. The Officers of RAPS shall take office as of 1 January of the year following their election.

    Section 3. Chairman

    The Chairman is the chief elected official of RAPS and will 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 RAPS following the completion of the term as Chairman.

    Section 4. President

    The President of RAPS will 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 will perform other duties, as assigned by the Chairman.

    Section 5. President-elect

    The President-Elect will assume without election the office of President at the expiration of the term of the incumbent. The President-Elect is responsible for becoming acquainted with the functions of the President and Chairman and performing other duties, as assigned by the Chairman.

    Section 6. Treasurer

    TheTreasurer will review the financial status of RAPS at least quarterly and will ensure all financial processes follow good business practice. The Treasurer will chair the Finance Committee and will report on financial status at every meeting of the Board of Directors. The Treasurer is authorized to sign all legal documents requiring the signature of a Board Officer.

    Section 7. Executive Director

    The Executive Director is the Chief Staff Executive of RAPS and is responsible for operating all facets of RAPS, overseeing all RAPS offices and staff organizing and supporting meetings of the Board of Directors. The Executive Director shall be responsible for providing direction and advice to the Board of Directors and will serve as the Secretary of the Society, ensuring all notices of meetings, minutes and other documents are prepared and maintained, and authenticate the records of RAPS. The Executive Director or his/her authorized designee shall be responsible for signing all contracts on behalf of RAPS, subject to the signature authority and policies developed by the Board. The Executive Director has the authority and duty to implement the policies of RAPS in a lawful manner, in accordance with generally accepted business principles and standards. The Executive Director will serve on the Executive Committee and Board of Directors as an ex-officio, non-voting member. The Executive Director reports to the Executive Committe, and, if relevant, to all Directors. The Executive Committee is responsible for evaluating the Executive Director’s performance.

    Section 8. 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 otherwise unable to complete the term of office, a special nomination and election procedure will be enacted and the Voting Members will elect a successor to the office of President-Elect.

    If the 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.

    Section 9. Delegation of Duties

    One or more duties of any Officer of RAPS may be expressly delegated by the Board of Directors or by such Officer to one or more other Officers, employees or agents of RAPS, provided that, if such delegation is not to another Officer, then the Officer will supervise and oversee the actions of such employees or agents.

    Article VIII. Meetings of the Board of Directors

    Section 1. Regular and Special Meetings

    At least one regular meeting of the Board shall be held each year, and additional regular meetings of the Board of Directors will be held at such time and place as the Board may determine, or upon the call of the Chairman. Special meetings of the Board of Directors may be called by or at the request of the Chairman, or any two Directors. The person or persons authorized to call special meetings of the Board may fix the time and place of any special meeting of the Board of Directors called by them.

    Section 2. Notice of Meetings

    Notice of the time and place of all regular and special meetings will be given to each Director or Officer in a manner consistent with the Act, at least two (2) days before the applicable meeting.

    Section 3. Quorum

    A majority of the voting members of the Board of Directors shall constitute a quorum for the transaction of business at any meeting of the Board of Directors.

    Section 4. Action by Board

    With the exception of the Chairman and Executive Director, each Officer and Director is entitled to one (1) vote on all matters brought before the Board. The Chairman shall vote to break a tie vote. Unless otherwise prescribed, the act of a majority of members of the Board of Directors present at a meeting at which a quorum is present is the act of the Board of Directors. No voting by proxy is permitted.

    Section 5. Virtual Meetings

    Any person participating in a meeting of the Board of Directors may participate by means of conference telephone or by any means of communication by which all persons participating in the meeting may simultaneously hear one another, and such participation constitutes presence in person at such meeting.

    Section 6. Action without Meeting

    The Board may take action without a meeting if each member of the Board signs a consent describing the action to be taken and delivers it to RAPS. Action taken under this Section is the act of the Board when one or more consents signed by all of the members of the Board are delivered to RAPS, unless the consent(s) otherwise specify the time at which the action taken is to be effective. Such consent or consents may be executed and delivered to RAPS by electronic means, including email, and must be filed with the minutes of proceedings of the Board.

    Article IX. Committees

    Section 1. Standing Committees

    The Standing Committees of the Society are the Executive Committee, Nominating Committee and Finance Committee. The Executive and Finance Committees are committees of the Board of Directors (“Board Committees”), and will be permitted to exercise the authority of the Board of Directors, as delegated by the Board. The Board of Directors may create and appoint members to the Board Committees upon the approval of a majority of all members of the Board Directors. All Board Committees must be made up solely of members of the Board of Directors. The Board of Directors may establish other committees, task forces and appointed bodies to pursue the purposes of RAPS, provided any committees not consisting solely of members of the Board of Directors will not have the authority to act on behalf of the Board of Directors. All committees and appointed bodies must report to the Board of Directors, and the Board will exercise authority over procedures, services, programs and budgets of such committees and appointed bodies.

    Section 2. Executive Committees

    The Executive Committee will consist of the Chairman, President, President-Elect, Treasurer and the Executive Director in an ex-officio, non-voting capacity. The Executive Committee may act for the Board of Directors pursuant to authority delegated by the Board of Directors, and subject to the limitations set forth in the Act. The Executive Committee will provide input on Board meeting agendas and will be responsible for the hiring, annual review and termination of the Executive Director. A majority of the Executive Committee will 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 RAPS may require.

    Section 3. Nominating Committee

    The Chairman, with approval of the Board of Directors, will name a Nominating Committee consisting of not less than three (3) and not more than seven (7) Active Members in good standing, including the immediate past Chairman of the Board of Directors. The Nominating Committee will use its best efforts to select at least one (1) qualified candidate from the RAPS’ membership for each Officer and Director position to be filled.

    Section 4. Finance Committee

    The Finance Committee will provide input and guidance to the Board of Directors on financial processes and oversight, budget review and monitoring, and monitoring investments and investment policies. The Finance Committee also will serve as an audit committee, interfacing with RAPS’ independent auditors. The Finance Committee will review recommendations for the independent audit firm and for the investment firm and make recommendations to the Board of Directors regarding selection of such firms. The Finance Committee will be comprised of the Officers and will be chaired by the Treasurer. Additional members of the Board may be added to the Finance Committee. The Finance Committee will report to the Board of Directors at every meeting.

    Article X. Finances

    Section 1. Fiscal Year

    The Board of Directors will determine the fiscal year of RAPS.

    Section 2. Budget

    The Board of Directors will 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. If the RAPS staff requests revisions to the budget, this would need to be approved by the Board as well.

    Section 3. Audits

    The accounts of RAPS will be audited annually by an independent certified auditing firm, which will be approved by the Finance Committee. The auditors will present their findings to the Finance Committee. The full audit report and related documents will be presented to the full Board of Directors at the conclusion of the audit.

    Article XI. 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 Voting Members. Proposed changes to the Bylaws from the Voting Members must be submitted to the Board of Directors at least ninety (90) days before the date designated by the Board of Directors for the annual business meeting.

    Proposed amendments to the Bylaws must be approved by two-thirds of the Board of Directors prior to being sent to the RAPS membership at least forty-five (45) days before RAPS’ annual meeting. Voting will be conducted in accordance with the provisions of these Bylaws and may be conducted by ballot or by vote at a meeting. Unless otherwise stated, amendments to the Bylaws will become effective at the beginning of the next fiscal year.

    Article XII. Limitation of Liability, Indemnification, and Insurance

    Section 1. Limitation and Liability

    The personal liability of the Officers and Directors of RAPS is hereby eliminated to the fullest extent permitted by law and by the provisions of the Act. Specifically, and without limitation, a Director or Officer of RAPS will not be liable to RAPS or its members for money damages for any action taken, or failure to take action, as a Director or Officer, except for liability for (i) the amount of financial benefit received by the Director or Officer to which the Director or Officer was not entitled; (ii) an intentional infliction of harm; (iii) an unlawful distribution authorized by the Officer or Director in a manner outside the standards of conduct mandated for the Officer or Director by the Act; or (iv) an intentional violation of criminal law.

    Section 2. Indemnificationn

    RAPS will indemnify its Directors and Officers in accordance with and to the fullest extent permitted by law.

    Section 3. Insurance

    The Corporation may purchase liability insurance for the indemnity specified above to the fullest extent as determined from time to time by the Board of Directors of RAPS.

    Questions or comments for the RAPS Board of Directors? Please contact nominations@raps.org.