RAC Recertification
Introduction
This guide presents the requirements and processes related to maintaining the Regulatory Affairs Certification (RAC) credential. The
requirements and standards for recertification are developed and administered by the Regulatory Affairs Certification Board (RACB),
which also manages all other facets of the RAC Program. Additional information on Regulatory Affairs Certification and recertification is
available on the RAC website at raps.org/RAC
Purpose of Recertification
The regulatory profession is knowledge-driven, since it is essential for the professional to be continually aware of changing regulations
and other areas related to the healthcare product lifecycle. Continual learning and professional development reinforce the critical role
and status of the regulatory profession.
Recognizing the diversity in the scope of practice and range of approaches to professional development for regulatory professionals,
the RACB developed a recertification framework that allows flexibility in the content and approaches to meet individual knowledge and
professional development needs. This recertification guide outlines a wide range of opportunities for earning recertification credits. The
RACB also recognizes that there may be other relevant opportunities not covered in this guide and invites RAC-credentialed professionals
to contact the RACB for guidance on any activities not specifically represented herein.
General Requirements
The required 36 professional development credits may be accumulated through a wide range of professional activities, related to the
regulatory profession, the biomedical sector and healthcare product lifecycle, and related areas of professional development (e.g.
business and management). Credits may also be earned through speaking, writing and leadership roles in professional organizations
related to the regulatory profession and healthcare product sector.
For professionals who hold more than one RAC certification, a single recertification is required to maintain all RAC credentials.
Categories for Earning Recertification Credits
The primary categories for earning recertification credits are summarized in the table below:
PROFESSIONAL DEVELOPMENT AREA
CREDITS
Training, Education Participation
Training and/or educational programs directly related to the scope of practice of a regulatory professional
offered by professional societies, trade associations, higher education institutions, educational service
companies or government agencies. This may include sessions dealing with preclinical, clinical,
manufacturing, quality assurance or quality control, compliance, postmarket surveillance and other topics
relevant to regulatory issues.
1 credit per hour
3 credits per half day
6 credits per day
12 credits maximum per multiday event
Online or other self-study courses related to the scope of practice of regulatory professionals offered by a
qualified, recognized organization. Course must include some type of assessment or evaluation procedure.
1 credit per course hour
12 credits maximum per course or as
designated by the provider
Web-based conferences on topics relevant to the scope of practice of regulatory professionals, including
relevant business and management topics.
1 credit per hour
1.5 credits per 90 min
Training or education related to the biomedical/healthcare sector; related scientific, clinical or engineering
disciplines; business; law or other fields. These meetings may represent the individual’s primary technical/
scientific field, general business/management enhancement, or other disciplines or topics not specifically or
solely focused on regulatory related issues.
1 credit per hour
3 credits per half day
6 credits per day
12 credits maximum per multiday event
PROFESSIONAL DEVELOPMENT AREA
CREDITS
University courses related to the scope of practice of regulatory professionals. This may include coursework
related to business management. Course must be full quarter or semester courses.
15 credits per semester; 10 credits
per quarter with maximum of 30 credits
per year
Additional Certifications Earned During This Recertification Cycle
Additional RAC examination(s) passed. Successful completion of new RAC examination must occur during
the recertification renewal period.
20 credits per examination passed
Other relevant certifications earned (e.g. quality, clinical research).
5 credits per examination
Course Organizer, Faculty, Speaker
Faculty, instructor or speaker at a regulatory related training or educational program, course or RAC study
group, requiring preparation of course materials or handouts in addition to presentation. Subject matter
must be related to the regulatory profession, including related business and management functions.
4 credits per hour of instruction
Faculty or instructor regulatory related course offered by an accredited university or college, requiring lecture
and preparation of course materials.
4 credits per hour of instruction
16 credits maximum per course
Presentations that are repeated may not be included unless content has been revised.
Panel member or respondent on regulatory topics and issues not requiring preparation of course materials or
handouts.
2 credits per hour of presentation
Member of organizing or planning committee for a training/educational program, course or conference track
or session related to regulatory. Additional credits can be earned for speaking at this event. Presentations
should be noted separately from role as organizer.
2 credits per program, course
Instructor or speaker on regulatory-related presentations or training programs within your organization. If
presentations are offered on a single topic throughout a year, list topic and total presentations for the year.
This does not include presentations completed on company-specific information which is part of one’s paid
position.
4 credits per hour of instruction
Articles, Books and Other Published Content
(May include materials published in print and/or electronic format.)
Each published, peer-reviewed article and/or chapter on topics/issues/advances related to regulatory
issues or the regulatory profession appearing in newsletters, magazines, journals, books, or published as
monographs or booklets.
5 credits per article
Author of book addressing issues/topics relevant to regulatory profession.
Based on length and topic; maximum of
15 credits
Editor, member of editorial or peer-review board of journal, magazine or book related to regulatory profession
that requires publication planning, author management and review
5 credits per publication
Brief editorials or columns (less than one printed page) and/or Letters to the Editor related to regulatory
published in professional publications.
1 credit each
Internet website developer, manager or editor for sites related to regulatory.
Credits determined on review by RACB
RAC Examination Questions
Development/submission and acceptance of questions and distracters for any RAC examination. Questions
must include identification of relevance to the content outline for the examination, item type analysis or
application, identify correct response and provide the relevant reference.
3 credits per question with correct
response, distracters and references
2 credits for each question with correct
response, reference and no distracters;
Leadership in Relevant Professional and Trade Organizations
Officer or board member.
2 credits per year of service
Committee or section chairman.
2 credits per year of service
Member of a committee, task force, council or other appointed group .
1
1 credit per year of service
Other
The RACB and the RAC Program Office may identify other special initiatives, including participating in
research studies on the profession, that are eligible for recertification points. These special initiatives and
other eligible professional development opportunities will be announced to RAC professionals via email and
on the RAC website.
RAC professionals may also contact the RAC Program Office and request consideration of professional
development activities not covered in the above categories.
RAC Recertification
Determined on a case-by-case basis
RAPS.org/RAC
Tracking Professional Development Activities
Most professionals will find it effective to track their professional development activities immediately upon completion. RAC
professionals who are active members of RAPS, have access to the Professional Development Manager, a transcript tracking service
enabling them to access, modify and print records of participation. All activities offered through RAPS, including training, education and
volunteer activities, are automatically recorded in an individual’s personal transcript. Other activities can be entered onto the transcript
by the member. A sum of total credits will appear in the transcript, making it easy to track professional development credits to date.
Professionals who are not RAPS members are encouraged to keep a record of each relevant activity, date and accumulated credits. It
may also be helpful to store agenda and other material related to each activity in the event of an audit.
Audit
The RAC Program Office audits a percentage of recertification applications. Proof of credits reported is not required during initial
submission, but must be available if requested. The RAC Program Office will randomly select among submitted applications.
Recertification Cycle
Professionals who hold one or more RAC credentials must recertify every three years. Recertification is due by 15 December three years
after receiving the RAC. The recertification initially begins on 1 January after earning the RAC. Certificants will receive information on
when recertification is due with their notification materials and will receive periodic reminders about the recertification requirements.
However, it is the individual’s responsibility to ensure that the RAC Program Office has up-to-date email and other contact information
and to ensure recertification materials are submitted by 15 December in the year they are due. Individuals who fail to recertify will not be
listed as an RAC. See “Reinstating RAC Status” below.
A Recertification Application may be submitted any time once 36 credits are accumulated. The recertification renewal schedule will remain
on the original three-year cycle. Points earned from the current recertification cycle cannot be forwarded to the next recertification cycle.
Professionals with more than one RAC credential are ONLY required to submit a single recertification, which is based on the cycle
established with their first certification.
Recertification Application
RAC professionals must complete and submit the RAC Recertification Application. The application is available for online completion, in
PDF format or as a Microsoft Word form. Professionals who are members of RAPS may complete first page of the application and attach
a copy of their personal continuing education transcript tracking form. Individuals who are not members of RAPS are required to provide
information on their professional development activities in the space provided on the application.
Recertification Fees
For applications submitted by the 15 December deadline, the recertification fee is $100 for RAPS members and $310 for nonmembers.
Payment must accompany the RAC Recertification. Late fees apply if not submitted by the due date. Applications will not be accepted
without payment.
Notification
RAC professionals will be notified via email within 15 business days of the acceptance of their recertification application.
Failure to Recertify or Meet Recertification Requirements
Professionals who do not acquire at least 36 professional development credits by their recertification date or who fail to submit the
recertification application will be notified via email of the suspension of their RAC designation, within 60 days after the 15 December
submission deadline. The individual will not be listed as an RAC until he or she meets conditions for reinstating his or her RAC status.
Reinstating RAC Status
The conditions for reinstating RAC status are:
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Submission of recertification credits for the current three-year time period and late payment. When five years have passed from the
recertification deadline, the individual will be required to retake the RAC examination, following all procedures and requirements.
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Payment for late submission is an additional fee of $50 for each year, in addition to the $100 recertification fee (plus a $185
nonmember fee for those who are not active RAPS members).
RAC Recertification
RAPS.org/RAC
Temporary Waiver
Provisions for temporary waivers of recertification credits will be extended if:
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An RAC professional does not currently hold a paid position related to the regulatory profession.
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An RAC professional is elected or appointed to full-time public office at the local, state or national level.
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Serious illness and/or disability limiting an RAC professional’s ability to meet the recertification requirements
A request for waiver must be submitted in writing by 15 June of the year in which recertification is due. Waiver requests will be reviewed
and approved by the Regulatory Affairs Certification Board (RACB). Waivers of professional points will not be granted for more than one year
unless medical documentation is provided and are subject to review by the RACB. Individuals granted a temporary waiver from recertification
will not be included in listings of RACs during the time the waiver is in effect.
Emeritus Status
Professionals with an RAC who are more than 60 years of age and retired from active practice of the regulatory profession, but who
wish to remain affiliated with the RAC program, may apply for an emeritus status. Requests for this designation must be submitted in
writing to the RACB, together with a $100 (RAPS members) or $310 (nonmember) one-time fee. If approved by the RACB, individuals may
use the “RAC Emeritus” title and will be included in a separate section in RAC listings. Emeritus individuals found to be using the RAC
credential outside of its intended purpose, i.e. as part of employment advertising, will be contacted and may lose emeritus status.
Release of Information
A full list of RAC professionals will be posted on RAPS.org. For RAC verification purposes, the RAC Program Office will confirm if an
individual is an RAC and which RAC certification earned. The RAC program Office will not confirm the date of completion and does not
have access to score details. RAC individuals should be diligent in renewing the credential. If you are an RAC professional and do not
see your name listed as such on RAPS.org, please contact the RAC Program Office immediately.
Footnotes
1
A
dditional points may be accumulated for special work produced by a committee such as white papers, standards or other materials of significance to the profession.
Individuals may request additional points through a written request to the RACB which includes a description of the outcome or product and its importance to the profession
and/or regulatory community.
RAC Recertification
RAPS.org/RAC