Regulatory Affairs Professionals Society
Editorial Advisory Committee (EAC)
Policies and Procedures
 
Purpose
RAPS’ strategic priorities are to:
  1. Proactively address evolving regulatory competencies required for the global profession
  2. Deliver valuable and accessible learning and professional development experiences
  3. Inform regulatory professionals of complex and evolving healthcare product regulatory developments
  4. Empower a community focused on interactions, relationships and knowledge-sharing
 
To help fulfill these strategic priorities, the society aims to develop a wide range of publications and resources to address the wants and needs of regulatory professionals who deal with a diverse range of healthcare product types, lifecycle phases and geographic locations. This includes books, feature articles, case studies, interviews, white papers, article series and other content. The Editorial Advisory Committee (EAC) assists RAPS in determining the topics that will be of most interest and use to regulatory professionals and helps identify potential authors and subject matter experts.
 
Scope
  • Further the society’s mission by expanding and improving published content available to regulatory professionals.
  • Support RAPS’ educational mission by recommending publications and resources to complement in-person and online programs.
  • Help identify and assess regulatory professionals’ unmet needs and prioritize where RAPS can add value.
  • Promote the exchange of ideas and information by suggesting authors, reviewers and committee members.
 
RAPS Editorial Advisory Committee (EAC) Responsibilities
The primary purpose of this committee is to:
  • Assist in developing a publications and editorial calendar for each calendar year, including monthly themes and recurring topics for Regulatory Focus articles.
  • Recommend further topics for consideration 24 to 36 months into the future.
  • Suggest authors for publications and articles.
  • Discuss topics with potential authors to facilitate production of new publications.
  • Suggest technical reviewers for feature articles and books.
  • Review articles and chapters based on areas of expertise.
 
The EAC shall be accountable to RAPS’ senior editors.
 
Composition, Structure and Size
The EAC will be assembled to include the diverse perspectives evident among RAPS’ membership. Thus, to the extent possible, EAC membership should include representatives from all sectors of the regulated industry (drugs, biologics, devices, IVDs, related areas), FDA and other regulatory agencies and academia; members with an understanding/awareness of global issues/needs; and members with a range of professional experience (newcomers to regulatory affairs to experienced and senior management levels).
The EAC will be organized under a single chair with three sector leaders responsible for biopharmaceuticals, medical devices and science and technology (addressing other topics).
 
The body of the EAC shall consist of at least 18 RAPS members in good standing; each designated to one of the three industry sectors. Every effort will be made to balance the three sectors. Potential members can be nominated by the EAC chair, sector leads, EAC members, RAPS members and RAPS staff in addition to random and/or unsolicited requests. Nominations are to be sent to the senior editors for review and EAC chair approval. 
 
Each sector will be dedicated to developing themes and content requirements for Regulatory Focus (formerly the printed, monthly magazine, delivered digitally on the RAPS website), related delivery channels and books. Specifically, they will be responsible for the following:
 
Books
  • Discuss topics and decide which are most appropriate for publications longer and more in-depth than feature articles.
  • Review publication proposals, making suggestions for any changes, and approving or vetoing.
  • Help identify project managers/leads for topical books.
  • Help identify authors for all publications.
 
Regulatory Focus Articles
  • Recommend issue leaders and co-leaders for each month. Senior EAC members (at least 12 months on the committee) should serve once as monthly leaders; junior members serve as co-leaders.
  • Recommend authors for any topics of interest.
  • Participate in monthly conference calls; provide feedback on agenda.
  • Attend one face-to-face EAC meeting; if they cannot attend in person, teleconferencing is acceptable.
  • Recommend topics for monthly themes and create yearly editorial calendar.
  • Review articles for timeliness, relevance to audience, quality of presentation, technical accuracy and areas for improvement within specified deadlines.
  • Actively recommend and recruit reviewers.
 
Ongoing Duties
  • Create narrative description of topic to be covered.
  • Create issue template with individual article topics and potential authors.
  • Initiate work on the issue eight months before the issue date by contacting the co-lead by phone or email and determining who will focus on recruiting authors for each article.
  • Develop ideas about the content and focus of the feature articles related to the issue theme and department articles. Each issue should have at least 12 articles— six to eight specific to the theme and four to six recurring departments.
  • Solicit authors for feature and department articles from industry, government, academia, etc.
  • Ensure there is a global focus to the issue and that it does not focus solely on FDA or US regulations.
  • Talk with authors who submit unsolicited feature articles or topics to determine whether the article is appropriate for their issue.
  • Review submitted articles to ensure the content is accurate and acceptable for publication in RAPS Regulatory Focus.
  • Help keep issue on schedule.
  • Create the first draft of the issue topic overview, unless another arrangement is worked out between the issue leads and the senior editor is notified.
 
Technical Reviewers
  • Review at least 12 articles per year.
  • Provide feedback on timeliness, relevance to audience, quality of presentation, technical accuracy, and areas for improvement within the specified deadline.
  • Actively recommend and recruit reviewers.
 
EAC Chair
The EAC chair must be a committee member when nominated. The two-year term begins 1 January in the year after selection. During their second term year, the EAC chair will, with advice and input from EAC members and RAPS staff, identify a nominee to serve as the new chair. That individual will then serve as “vice chair,” assuming the leadership the following year. This person will be selected at the autumn EAC meeting. The EAC Chair shall:
  • attend the June planning meeting in Rockville, MD and the EAC meeting during the convergence each fall
  • consult with RAPS’ senior editors prior to each meeting regarding the agenda
  • discuss policies related to RAPS publications and the EAC with RAPS senior editors
  • mentor EAC members to ensure their activities are aligned with RAPS publications policy
  • recommend removing EAC members before their terms expire if they are unable or unwilling to complete tasks requested of them
  • work closely with other pertinent RAPS committees to ensure all aspects of RAPS’ publications are closely tied to the society’s objectives and action plans
 
Length of Service
EAC members serve three-year terms. They must be RAPS members in good standing at the time they begin serving on the committee. If an EAC member does not renew his or her RAPS membership during his or her term, the member will be removed from the panel at the end of the year his or her RAPS membership expires. EAC members may serve a maximum of two consecutive terms.
 
Meetings
The EAC shall hold one meeting each year during the RAPS annual conference. EAC members are expected to attend the autumn meeting in person or via conference call. Conference calls or email shall be used for any special matters that arise and that cannot wait until the next scheduled meeting. The publications calendar for the following year is finalized at the autumn meeting.
 
Remuneration
The EAC shall consist of volunteer member of RAPS and shall serve without remuneration.