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RAPS Introduces Pharmaceutical- and Medical Device-Focused Regulatory Affairs Certifications (RACs)

Posted 03 October 2018 | By Zachary Brousseau 

RAPS Introduces Pharmaceutical- and Medical Device-Focused Regulatory Affairs Certifications (RACs)

RAPS today announced two new Regulatory Affairs Certifications (RACs) will become available beginning with the next RAC exam period in spring 2019. Exam applications are now being accepted. The two new exams and associated credentials are called the RAC (Drugs) and RAC (Devices). They join the four previously established, regional exams: US, EU, Canada and Global.

The RAC is the only post-academic professional credential for the healthcare product regulatory field. Today’s announcement was made during the RAPS Regulatory Convergence conference taking place this week in Vancouver.

RAPS Executive Director Paul Brooks explained the reason for separate credentials devoted to pharmaceutical and device regulation, respectively. “The regional RAC exams, such as for the US or EU, require extensive regulatory knowledge for products that are quite different and are regulated differently. And while many regulatory professionals work across different product types, many are specialists working predominantly in a primary product sector,” said Brooks. “We listened to increasing calls for sector-specific RACs from our regulatory community. Over the past year, the RAC Board explored the demand for, and feasibility of, these exams and confirmed there was a need that RAPS could and should meet.”

Just-released results of RAPS’ Compensation & Scope of Practice Survey also support this conclusion as it found that, on average, regulatory professionals spend 86% of their time on a primary product area, and more than half devote 100% of their time to a single product type. Now those who wish to pursue the RAC have the option of taking one of the existing region-focused exams or a new sector-focused exam.

The RAC (Devices) exam will test knowledge of the full product development and lifecycle requirements for medical devices and IVDs under US and European regulations and guidances, as well as globally applicable regulatory practices. The RAC (Drugs) exam will cover the equivalent scope for pharmaceutical, medicinal and related products, APIs, biologics, and biotechnology products.


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