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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.
Euro Convergence 2020 is moving towards a rewarding week. We are now offering an enhanced hybrid format with both in-person and online sessions from Monday 26 to Friday 30 October 2020.
Learn how recent changes to the regulation of healthcare products in the EU will impact you as a regulatory professional.
In light of the COVID-19 pandemic, the RAC Board has elected to offer online testing with live online proctoring this summer.
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Posted 13 February 2018 | By Zachary Brousseau
RAPS is pleased to announce that 248 regulatory professionals passed the Regulatory Affairs Certification (RAC) exam during the autumn 2017 testing period, thereby earning the RAC credential.
The RAC is the only professional credential for regulatory professionals in the healthcare product sector. Certification must be maintained through continuous learning and professional development, and renewed every three years. Currently, there are more than 4,500 RAC-credentialed professionals worldwide.
“Congratulations to the latest successful class of applicants for the RAC credential, and to all current holders of the RAC,” said RAPS Executive Director Paul Brooks. “RAC-credentialed professionals not only demonstrate current knowledge of relevant regulations and the critical thinking skills to apply them in a variety of situations, but also have several years of practical RA experience and have committed to improvement of the regulatory affairs profession via continuous learning and growth.”
See below for the complete list of professionals who attained the RAC credential in autumn 2017.
There are four different RAC certifications available: the RAC (US) covering US regulations, the RAC (EU) covering European regulations, the RAC (CAN) covering Canadian regulations and the RAC (Global), which covers general regulatory responsibilities and international standards. RAC exams and the criteria for maintaining the credential are developed, managed and administered by the Regulatory Affairs Certification Board (RACB) with support from RAPS.
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