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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.
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.
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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RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.
Include your name on the application as it appears on your government-issued photo identification (ID). If your name on your application does not match the government id, you will not be allowed to sit for the exam at the testing venue.
Provide a valid e-mail address that will be maintained throughout your RAC application period. If you choose to provide a work e-mail address, please keep in mind that any change in your employment during your application may mean you no longer have access to that e-mail account. email address. All communications about your RAC examination, including information about scheduling your examination and examination results, are electronic. Please contact the RAC program office at certification@raps.org if there is any change in your email address after you have submitted your application.
Complete the RAC examination application fully. As part of the application process, you must attest to the following:
Incomplete applications will delay processing and may cause your application to be rejected if not completed by the application deadline.
The RAC Candidate Guides contain all the information you could need about the exam process in a single pdf document. Download the 2019-2020 RAC Exam Candidate Guides:
RAPS may audit a percentage of applications for completeness and accuracy. If your application is selected for audit, you will receive email notification of the audit, what types of documentation must be submitted and the deadline for submission of requested documentation. If you do not comply with the terms of the audit by the stated deadline, you will not be allowed to take the test and your examination fee will be refunded minus a $100 processing fee.
If your application is incomplete, you will be notified by the RAC program office, and the application deficiencies must be corrected by the application deadline. Failure to submit required information prior to the deadline will lead to rejection of your application and you will be issued a refund of the examination fee, minus a $100 processing fee.
Applications for RAC examinations will be rejected for failure to meet eligibility requirements or falsification of application information. Rejected applicants will be refunded the examination fee, minus a $100 processing fee.
An application may only be withdrawn or cancelled before the application deadline. Requests to withdraw or cancel an application will not be accepted after this deadline. To withdraw or cancel an RAC application, you must submit a written request to the RAC program office at certification@raps.org. There is a $100 processing fee for withdrawn or cancelled applications.
A request to transfer to the next testing cycle may be made without charge before the application deadline. Requests to transfer to the next testing cycle after the application deadline but before the end of the testing window will incur a transfer fee of $250. Transfers will be allowed up to 10 days after the end of the testing window. After this period transfers will not be allowed and applicants will be required to pay a new application fee at full price. For individuals who require a transfer due to an unavoidable emergency please see the ‘Emergency Situations’ section.
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.
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