Professional development in regulatory affairs since 1992
NCRAF's Spring Summit will have a return engagement by former FDA Commissioner
Dr. Robert Califf
Wednesday, May 17, 2017
RAC(US) Workshop Seminar Series
Tuesdays starting June 6, 2017 and continuing until September 26, 2017, 6:00 - 8:00 pm
Location: DCRI, The Lower Level Conference Room (NOTE: This is NOT the Downtown Office)
RAC EU online Workshop
Register for the self-paced course starting Feb. 7, 2017
ECTD Group Meetings
These meetings have resumed as quarterly get togethers for 2017
Bylaws of NCRAF (as amended January 6, 2010) (PDF Document):
Article I - Name
The name of this organization shall be the North Carolina Regulatory Affairs Forum (NCRAF).
Article II - Type of Organization
NCRAF shall be a nonprofit corporation in perpetuity under the laws of the State of North Carolina. The officers of NCRAF shall serve as directors of the corporation, and shall file and maintain Articles of Incorporation with the Department of the Secretary of State of North Carolina.
Article III - Purpose
The purpose of NCRAF is to provide a local forum for the exchange of information regarding regulatory affairs activities as they apply to organizations in research, development, or manufacture of drugs, biologics, or medical devices. NCRAF is dedicated to providing education and support for the continuing professional development of individuals who have an interest in regulatory affairs.
Article IV - Membership
Individuals shall become members of NCRAF upon payment of annual membership dues. All individuals, and particularly individuals currently working, or with experience, in regulatory affairs, may become members. Only NCRAF members in good standing shall be entitled to vote for the election of officers and to hold office as officers or standing committee chairpersons.
Article V - Membership Dues
Section 1– Annual Dues
Membership dues for each year shall be paid annually in the amount set periodically by the Executive Committee. Membership dues are nonrefundable and are applied to the individual named in the membership application only.
Section 2– Lifetime Dues
The Executive Committee may establish optional lifetime membership dues as an alternative to annual dues.
Article VI - Executive Committee
The Executive Committee shall consist of the officers, the chairpersons of the standing committees, and the Past-President. The President of NCRAF shall chair the Executive Committee. The Executive Committee shall be the governing body of the organization. It shall control all the activities of the organization, including policy and administrative affairs, and have all the powers of the general membership when general membership meetings are not in session, except that the Executive Committee may not elect officers other than as provided under Article VII, Section 3. The Executive Committee shall set the amount of membership dues as provided under Article V, above, and shall establish fees and assessments for special purposes and events as needed.
Article VII - Officers
The officers of NCRAF shall be a President; a President-Elect; a Vice President, Programs; a Vice President, Communications; a Recording Secretary; and a Treasurer. All officers shall be NCRAF members in good standing.
Section 1 - Duties of Officers
The duties of the officers shall be as follows:
The President shall preside at all meetings of NCRAF and of its Executive Committee; shall supervise the affairs of the organization; shall, with the concurrence of a majority of the officers currently serving, appoint the chairpersons of those standing committees for which chairpersons are not elected; shall serve as an ex-officio voting member of each of the standing committees; and shall have all executive powers normal to this office, except as otherwise provided in these bylaws.
The President-Elect shall assist the President in all duties of that office; shall, in the absence of the President, serve as Acting President with all of the authority and responsibilities of the President; and shall succeed to the office of President upon completion of the President’s term of office or upon the incapacity or resignation of the President.
C. Vice President, Programs
The Vice President, Programs shall chair the Programs Committee and shall, in the absence of both the President and the President-Elect, serve as Acting President with all of the authority and responsibilities of the President.
D. Vice President, Communications
The Vice President, Communications shall chair the Communications Committee.
E. Recording Secretary
The Recording Secretary shall keep minutes of all meetings of NCRAF and of its Executive Committee, shall keep the nonfinancial records of the organization, other than those that are the responsibility of the Vice President, Communications; shall preserve the records of the organization and see that they are transmitted to succeeding officers; and shall have authority and duties appropriate to this office, except as otherwise provided in these bylaws.
The Treasurer shall conduct the financial transactions and keep the financial records of the organization; shall report on the financial status of the organization at its meetings, at meetings of the Executive Committee, or when so requested by the President; and shall have authority and duties appropriate to this office, except as otherwise provided in these bylaws.
Section 2 - Election of Officers
Officers shall be nominated and elected by the membership.
Section 3 - Terms of Office
Officers shall be elected for one year terms beginning with their installation and continuing until their successors are installed. The President-Elect, upon completion of their term of office or upon a vacancy in the office of President, shall succeed to the office of President. In the event of a vacancy in the office of President-Elect, the remainder of any vacant term may be filled by appointment by the Executive Committee with the concurrence of the President. A President-Elect thus appointed by the Executive Committee shall not automatically succeed to President without a vote of the membership. In the event of vacancies in any office other than President or President-Elect, the remainder of any vacant term may be filled by appointment by the President with the concurrence of the Executive Committee.
Article VIII - Standing Committees
Chairpersons and members of standing committees shall be NCRAF members in good standing. The duties of the standing committees shall be as follows:
Section 1 – Programs Committee
The Programs Committee shall be chaired by the Vice President, Programs. Members are appointed by the chairperson. The Programs Committee shall, in consultation with the Executive Committee, establish topics and identify speakers for programs to be presented at NCRAF membership meetings. The committee shall make arrangements for facilities and refreshments for membership meetings, shall prepare meeting announcements for distribution to the membership, and coordinate meeting registration. The Professional Liaison is a member of the Programs Committee and shall initiate contact with FDA on behalf of members (e.g., to propose presentation topics and invite FDA speakers for NCRAF meetings, etc.). The liaison shall also be the initial point of contact to foster relationships and at the direction of the Vice President, Programs coordinate joint meetings with other local professional organizations that have similar missions. The liaison shall apprise the Programs Committee of professional development opportunities available through local organizations.
Section 2 – Communications Committee
The Communications Committee shall be chaired by the Vice President, Communications. The NCRAF newsletter editor, the NCRAF webmaster, and the NCRAF Advertisement Coordinator shall be members of the Communications Committee. Members are appointed by the chairperson. The Communications Committee shall keep the membership records of the organization; shall distribute meeting announcements, newsletters, and other official publications of the organization authorized by the Executive Committee; shall assure that the NCRAF website contains current information; and shall coordinate advertisement postings in the newsletter and on the website.
Section 3 – Education and Training Committee
The chairperson(s) of the Education and Training Committee shall be appointed by the President in consultation with the Executive Committee. Members are appointed by the chairperson(s). The Education and Training Committee shall coordinate member training focused on preparation for professional certification examinations. The Committee shall identify topics and speakers, determine the meeting schedule, arrange for facilities, and prepare course announcements for distribution to the membership. In addition, the Committee shall consult with the Executive Committee to confirm the current membership status and payment of training fees for each participant.
Section 4 – Nominating Committee
The chairperson of the Nominating Committee shall be the President of NCRAF. The President-Elect and Past-President will also serve on the Nominating Committee. The Nominating Committee shall coordinate votes by the membership to elect officers or amend the bylaws. The Committee shall resolve any questions regarding the voting eligibility of any member or the acceptability of any ballot, tally the votes, and report the results to the Executive Committee and the membership. For the election of officers, the Nominating Committee shall solicit nominations for officers from the membership of the organization, shall review the nominations for eligibility, and shall present a slate of no more than three candidates for each office to the membership at least one month prior to the Annual Meeting each year.
Article IX - Special Committees
Special committees may be appointed by the President or by the Executive Committee whenever necessary to carry out the purposes of NCRAF.
Article X - Meetings
Section 1 - General Membership
It is the intention that NCRAF hold a minimum of six general membership meetings per year, at least one meeting per quarter. The Annual Meeting of the Membership shall be held during the first quarter of each year, at which time the elected officers shall be introduced to the membership and shall assume their responsibilities. Special meetings may be called at any time by the President or by the Executive Committee.
Section 2 - Executive Committee
The Executive Committee shall meet at least bimonthly and at such other times as necessary to meet its responsibilities. These meetings shall be called by the President or by the President-Elect, or, if unusual circumstances warrant, by any other member of the Executive Committee. Notification of Executive Committee meetings shall be made by the person calling the meeting.
A majority of the Executive Committee members currently serving shall constitute a quorum. A quorum is necessary for all major Executive Committee decisions (e.g., significant expenditures or policy changes, Executive Committee member replacement, interpretation of NCRAF Bylaws, etc.).
Section 3 - Standing Committees
Standing Committees shall meet at such times as necessary to meet their responsibilities. Meetings of each Standing Committee shall be called by the chairperson of that committee or by the President of NCRAF.
The chairperson or the chairperson and one other member of any Standing Committee shall constitute a quorum.
Article XI - Election of Officers
Officers shall be nominated and elected by NCRAF members in good standing in a manner consistent with the following:
Section 1 - Nominations
The Nominating Committee shall solicit nominations for officers from the membership of the organization, shall review the nominations for eligibility, and shall present a slate of candidates for each office (the goal should be at least two candidates for each office) to the membership at least one month prior to the Annual Business Meeting each year.
Section 2 - Elections
The Nominating Committee shall be in charge of all elections, and votes shall be tallied by the Nominating Committee. Officers shall be elected by a plurality of the votes cast by secret ballot, prior to the Annual Business Meeting. Questions regarding the voting eligibility of any member or the acceptability of any ballot shall be resolved by the Nominating Committee. The results of the election shall be announced to the membership at the Annual Business Meeting by the Chairperson of the Nominating Committee, or, in the chairperson’s absence, by the presiding officer. Installation of officers shall take place at the Annual Business Meeting.
Article XII - Amendments to These Bylaws
Proposals for amendments to these bylaws may be made at any time, and shall be presented to the Executive Committee in writing. If the Executive Committee finds a proposed amendment to be consistent with the objectives of and in the best interests of the organization, it shall send the proposal to the Nominating Committee for presentation to the voting members by paper or electronic means. This written communication shall be sent to the member’s address that is on file in the NCRAF contact information. Approval shall be by majority vote, by secret ballot. The Nominating Committee shall oversee voting on proposed amendments and shall resolve any questions regarding the voting eligibility of any member or the acceptability of any ballot. Amendments so adopted shall become effective upon announcement by the Nominating Committee of the results of the balloting.
Adopted by the membership 01 November 2007