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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.
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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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Posted 07 February 2019 | By Zachary Brousseau
A total of 235 individuals earned Regulatory Affairs Certification (RAC) during the most recent RAC exam period, RAPS announced today. The challenging RAC exams test essential knowledge of healthcare product regulations, critical thinking and analytical skills. To pass, exam takers must be able to demonstrate not only that they know the relevant regulations, but also how they apply in a variety of realistic scenarios.
By passing, each of the 235 professionals now hold the sought-after RAC credential, the only professional credential specifically for the healthcare product regulatory field. To maintain it, RAC holders must recertify every three years through continuous learning, professional development and regulatory leadership activities, demonstrating their ongoing commitment to the profession.
“The RAC credential denotes so much more than just passing an exam,” said RAPS Executive Director Paul Brooks. “It indicates a level of professional competency that only comes through practice and dedication. RAC candidates must have gained real-world work experience to be eligible to take the exam. They also must be willing to invest the time and effort into their own professional growth to maintain the credential. The RAC demonstrates commitment to go above and beyond.”
Currently, there are six different RAC exams. Two industry-based exams—RAC Drugs and RAC Devices—which cover regulations for pharmaceuticals and medical devices, respectively, have been introduced for 2019. There are more than 4,500 RAC-credentialed professionals around the world.
The next RAC exam period will be this spring. Exams will be administered at locations around the world from 22 April to 31 May. Registration is now open for all exams. The deadline to apply is 21 March. For more information, click here.
Following is the complete list of those who earned the RAC credential in autumn 2018:
Tags: RAC, Regulatory Affairs Certification
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