Regulatory affairs just got easier

By Kirsty Barnes

- Last updated on GMT

Those in the regulatory affairs profession can now breathe a sigh
of relief as the industry-recognised accreditation process just got
a whole lot easier.

The Regulatory Affairs Professionals Society (RAPS), the worldwide member organisation for standards of ethics, credentialing and education for the pharma regulatory affairs profession has announced a dramatic increase in the locations and dates of examinations available to obtain the Regulatory Affairs Certification (RAC).

Until now, professionals wanting to take the accreditation exam only had one day of the year to do so, and with limited exam locations in place, often had to travel long distances.

With the new changes, individuals taking the RAC exam can now take the test on any date between 1 October and 30 November 2006, as well as choosing from hundreds of locations worldwide from where to take the test.

In addition, the test will be administered electronically on test-centre computers for the first time.

"The general content and multiple-choice format remain the same, but the ease with which professionals can test for the certification has vastly increased,"​ said Meredith Ellison, RAC spokesperson.

Regulatory affairs professionals are the conduit between drug and device manufacturers and the regulatory bodies and are involved in overseeing the regulation and quality assurance of a product through its entire lifecycle, including discovery and development, clinical trials, manufacturing and processing, distribution and marketing.

While the RAC is a voluntary certification, it demonstrates that the professional has a certain level of knowledge, skills and core competencies required in the context of the regulatory environment that they operate, RAPS executive director, Sherry Keramidas told In-PharmaTechnologist.com.

The exams are specifically tailored to suit those working in either the EU, US or Canadian regulatory environment.

Figures released in RAPS 2003-2004 Scope of Practice Survey show that more individuals at all professional levels have obtained the credential, for example, 33 per cent at the specialist level compared with 20 per cent at the same level in 2002.

"We are seeing a steady increase of the number of professionals seeking this accreditation and the new changes will only increase this number further," said Keramidas.

The same survey also showed that regulatory affairs professionals with the RAC are earning at lest 5 per cent more than comparable colleagues without the credential.

Registration for the next round of testing is open now.

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