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Emerging market regulatory staff should take test to level playing field, RAPS

By Natalie Morrison , 30-Aug-2012
Last updated the 30-Aug-2012 at 13:28 GMT

Regulatory professionals working for contract research organisations (CROs) in emerging markets could benefit from taking a test to bring them up to par with those in developed countries, according to RAPS.

In its recent Scope of Practice and Compensation report – which surveyed more than 3,000 regulatory workers in 58 countries – the society found that on average staff in charge of trials’ regulatory aspects in established markets like the US or Europe have more experience than those in emerging industries.

Speaking to Outsourcing-Pharma.com, Regulatory Affairs Professionals society (RAPS) executive director Sherry Keramidas said she believes the results boil down to the fact the regulatory professional role is “younger” in BRIC countries.

She said however that by taking a simple RAPS test called the RAC (Regulatory Affairs Certification) – a post academic credential for regulatory individuals – professionals could not only gain sponsors’ confidence by proving their knowledge, but could also boost skills by studying for the exam.

“I think it can help to eliviate problems in developing markets for instance with CROs,” she said. “It definitely highlights whether the professional has the core competancies and skills.”

Keramidas added that RAPS is currently working with a number of regulators including the World Health Organisation (WHO) and the US Food and Drug Administration (FDA) to boost capabilities in emerging countries, who have shown a big interest in the test.

She said that new developments could include a pre-examination for the RAC, especially for regulatory professionals in areas known to have had compliance issues.

“It may be done in steps, so they would have a pre RAC qualification before they take the actual RAC,” she told us.

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