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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.
RAPS Convergence is going virtual. Join the brightest minds in regulatory online to gain the latest knowledge in the field in an all-virtual experience with workshops, one-on-one expert sessions, and networking communities.
This year, our European regulatory community will converge online with a fully virtual program that will allow attendees to experience Euro Convergence live online from the safety and comfort of their homes.
RAPS' “how to” guide to developing a comprehensive global regulatory strategy for all types of medical devices. Updated September 2020.
The last exam window of 2020 is currently open. Register by 8 October to take the RAC exam this autumn.
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RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.
RAC examinations are scored by Scantron after the close of the testing cycle. Examinations are not scored at testing centers. A statistical report of scoring is reviewed by a statistician and the examination committee to assure ongoing quality of the examinations. All scores are reported on a scale of 0 to 99 with 75 being the passing score. The scaled score is neither the number of questions answered correctly, nor the percent of questions answered incorrectly. The scaled score cannot be used to determine the number of correctly answered questions needed to pass the examination.
Candidates will receive their scaled score, pass/fail status and a score report summarizing performance on each domain. Examination results are typically available four to six weeks after the close of the testing cycle. You will receive an email notification with your results. Results are released only to candidates. No results will be reported over the telephone or by fax. Candidates do not receive a copy of the examination, their examination score sheet, information on the performance statistics of specific examination questions or information on the performance of other individual candidates or group of candidates.
A list of all active RAC-credentialed professionals is available online as a PDF and as an interactive search tool. Newly credentialed professionals are added after all candidates are notified of their status. If you do not wish to be included in the online listing, please contact the RAC program office. Note: Certificants who do not maintain recertification will not be listed.
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The RAC program maintains strict procedures for ensuring the confidentiality of all candidate records. Information about candidates is released only to the candidates themselves. Scores are only released to the candidate and are not released by telephone or fax even to the candidate.
When you pass a RAC examination you may use the RAC designation after your name as a professional credential. You should list your RAC and specific RAC credentials on your resume, curriculum vitae, employment or other professional records. The RAC designation cannot be used by individuals who fail to maintain the RAC credential by meeting recertification requirements.
Candidates have the right to appeal any adverse decision made by the RAC program office. An appeal must be submitted in writing not more than 30 days following the date of notification of the adverse decision. Appeals should be sent to the RAC program office at certification@raps.org or via US mail to RAPS headquarters. All appeals will be addressed by the RACB. Decisions about appeals made by the RACB will be final.
Candidates who do not pass the RAC examination are eligible to retake the examination. To apply for re-examination, candidates must submit a new application. There is no limit on the number of times a candidate can take an examination. Candidates can retake the exam as soon as the next testing window.
An RAC certificant may lose RAC status based on any of the following:
Decisions to remove RAC credential(s) will be made by the RACB. This decision applies to all RAC credentials held by the individual. The individual will be notified in writing of the loss of the credential(s). The individual will not be listed in any publication or directory of RAC holders.