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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
Resources, news and special offers to support you and your professional development during this difficult time.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Convergence 2020 has come and gone, but you can still access recorded sessions, which are available to attendees until 31 December 2020.
Replay the moments of Euro Convergence 2020. Recorded sessions are available to attendees until 31 January 2020.
RAPS' “how to” guide to developing a comprehensive global regulatory strategy for all types of medical devices. Updated September 2020.
From self-assessments to help you identify your strengths and areas to focus on to reference books and online courses that will help you fill in the gaps in your regulatory knowledge, RAPS has the resources to help you prepare for the RAC exam.
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The RAPS website recently experienced issues that we continue to monitor. Certain areas of the site including news may be limited. We apologize for any inconvenience.
In addition to indicating thorough knowledge of regulatory, the RAC designation represents a commitment to ongoing education and professional development. After passing the RAC exam, RAC status is maintained by acquiring 36 hours of recertification credits every three years. Recertification credits are awarded for participation in educational and professional activities, including:
Log Your Credit Hours Online ->
Credentialed professionals holding more than one RAC credential are only required to submit a single recertification application containing 36 credits. The certification cycle for multiple credential holders is based on the date of the initial certification earned.
RAC Holders looking to recertify their RAC can now do so via online application using their RAPS login. Follow the online instructions to complete the application.
RAC ONLINE RECERTIFICATION INSTRUCTIONS
This video walks you through the new recertification process:
LOG IN NOW TO RECERTIFY
Member
Nonmember
Recertification
$180
$290
Late Fees (added to recertification fee above)
$150 (within one-year grace period)
$250 (within one-year grace period)
RAC Emeritus Status Application
$150
$250
The RAPS member rate applies only if you are a member at the time you submit your application. If you apply for RAPS membership prior to submitting an RAC application, please be sure you receive confirmation of your RAPS membership before you submit your RAC application. If you apply for RAPS membership after you submit an RAC application, RAPS will not refund the difference.
For information about RAPS membership visit RAPS.org/join-raps.
The correct payment must accompany your application. You may submit your application and payment in the following ways:
Apply online, by fax or postal mail to: Regulatory Affairs Professionals Society Attn: RAC Program Office 5635 Fishers Lane Suite 400 Rockville, MD 20852 USA
Postal mail only to: Regulatory Affairs Professionals Society RAC 5635 Fishers Lane, Suite 400 Rockville, MD 20852 USA
Fax a completed application form and copy of bank wire confirmation to confirm your application to: RAPS Account #1000043228997; ABA #061000104 Swift Code SNTRUS3A; Suntrust Bank, 303 Peachtree St. NE, Atlanta, GA 30308. Must reference name of candidate. All bank charges are the responsibility of the payer. For all wire payments: fax (+1 301 770 2924) or email (certification@raps.org) a completed form and copy of bank wire confirmation to confirm your registration.
A temporary waiver of recertification credits will be extended if:
A request for waiver must be submitted in writing 60 days prior to the certification expiration date. Individuals granted a temporary waiver will be listed as an RAC for up to 12 months. If the individual fails to recertify during the 12 month period, they will no longer be listed as an RAC and must re-take the certification examination to reinstate RAC status.
RAC-credentialed professionals who are more than 60 years of age, have been actively involved in the regulatory profession and retired from practice, but wish to remain affiliated with the RAC program, may apply for emeritus status. Requests for this designation must be submitted in writing to the RACB through the RAC Program Office, with a one-time $150 fee for RAPS members or a $250 for nonmembers.
Requests for emeritus status must be received prior to the certification expiration date. If approved by the RACB, individuals may use the “RAC Emeritus” title. Those holding emeritus status 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.
The RAC designation is revoked 15 days after the certificant’s recertification due date. The individual will not be listed as a RAC and will not be able to use the RAC designation until he or she meets conditions for reinstating the RAC status.
The RAC credential can be reinstated if recertification credits and fees are submitted within one year of the certification expiration date.
Recertification credits must be obtained during the three-year certification period. The recertification fee plus the late fee must be submitted with the completed RAC Recertification Application and Professional Development Tracker. RAC-credentialed professionals who recertify after, but within one year of, the certification expiration date, will maintain the original certification expiration date. The certification expiration date will not be adjusted based on the date of the late submission. After the one-year delinquency period, individuals will be required to retake the RAC examination in order to reinstate RAC status.
Failure to recertify within one year of the certification expiration date will inactivate all RAC credentials held by a credentialed professional. However, retaking the examination for one of the previously held RAC credentials will reinstate all previously held RAC credentials
DOWNLOAD THE RAC RECERTIFICATION GUIDE
Paper forms are linked below if needed, but we encourage you to use the new online process above.
Please see the step-by-step instructions on the RAC Recertification there is also a video walkthrough to help you with the process.
To access the RAC online recertification you will need to login to the RAPS website. Click your name at the top right to go to My Profile > Purchases > Certifications.
Select Forgot Password to reset your login (see instructions). If you have trouble logging in, it is best to contact the RAPS customer service team on 301 220 7970 extension 200 to establish your login and ensure it is linked to your RAC record. Do not create a new account, this will not link to your RAC record and you will not be able to recertify online.
To log and track your RAC credits you need to log into the RAPS website. The RAC program cannot verify your credits, and therefore your recertification application, without this. As an alternative you can submit the paper/pdf forms for the foreseeable future but we prefer you try the online system first.
The RAC program will continue to provide paper/pdf forms for the foreseeable future.
Yes. At this stage the system does not have the capability to automatically record credits earned through RAPS. For example, if you attend Convergence, you will still need to enter those credits yourself.
Yes. While the online credit tracking allows for credits to be entered, it does not currently allow for evidence of earned credits to be provided in the system. As such you should keep evidence, such as a certificate, record of attendance or similar documentation. This documentation should be kept for at least 12 months after recertification.
RAC recertification applications may be submitted up to one calendar year post-expiration, but expired recertification applications must use the paper forms and cannot be processed online. Paper recertification applications may be found here. If more than one calendar year has elapsed since your RAC expiration date, you will need to re-take the exam in order to regain your RAC credential.