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Posted 03 February 2015 | By Zachary Brousseau
Perhaps you have decided to pursue Regulatory Affairs Certification (RAC), or you are interested in it, but are unsure which of the four RAC credentials is the best fit for you. A previous article examined factors to consider in determining if the RAC is right for you. If you need to assess whether or not to pursue an RAC, you may want to start there. In this article, I will address the question of which RAC credential is right for you.
The four available credentials are the RAC (US), RAC (EU), RAC (CAN) and RAC (Global). Each requires passing a different exam covering different sets of regulations, standards and guidelines. All four exams are based on the actual work of regulatory professionals in the field. Each exam includes questions on multiple product types, including pharmaceuticals, medical devices and biologics, as well as critical thinking and analysis questions. The US, EU and CAN exams cover the regulations of the US, EU and Canada, respectively, while the Global exam covers the general scope of practice of regulatory professionals regardless of where they work, and international guidelines and standards that are relevant around the world.
For someone who works mostly with regulatory authorities in one particular region—either the US, EU or Canada—the choice of RAC credential should be fairly straightforward. If your work is primarily concerned with products marketed in the US and overseen by the US Food and Drug Administration (FDA) and other relevant US agencies, the RAC (US) is a good fit. The same holds true for the EU and Canadian credentials.
“I chose to get the CAN credential as most of the work that I do is for Canada,” says Tharshini Veerasingam, RAC, senior manager, regulatory and quality operations at Regxia Inc., in Toronto, Canada. “And when I did get my RAC, I was more familiar with the Canadian regulations and guidelines.”
The region on which your work focuses is the one for which you are most likely to have the necessary experience and knowledge to pass the RAC exam. Also, the credential associated with that region probably holds the most value for you.
The US credential continues to be the most popular, perhaps because it is the oldest, best-established of the four, or because the US is such an important market. “The US is still the largest market and everybody ultimately wants to go there,” says Ray Huml, MS, DVM, RAC, executive director of strategic drug development and head of global biosimilars strategic planning for Quintiles, Durham, NC. The RAC (US) also is accredited by the National Commission for Certifying Agencies.
Of course, many regulatory professionals are involved with multiple regions. Val Theisz, MSc, RAC, FRAPS, is head of regulatory affairs for Cochlear in Sydney, Australia, but her work covers the EU, the Middle East, Russia, Asia Pacific, the US, Canada and Latin America. She decided to get the RAC (US) and RAC (EU). “EU and US are the largest markets for medical devices and have the two most distinct regulatory regimes,” she says.
The newest, fastest growing and possibly least understood of the RAC credentials is the RAC (Global). While the US, EU and Canadian exams cover regional regulations, the Global exam is not tied to a particular regulatory system. The Global credential was established in 2009 in response to demand for a credential not centered on North American or European regulations. Professionals who work with authorities outside the US, EU or Canada, or who work with many different authorities, may want to consider the Global credential.
“I recommend that professionals dealing with a number of different geographic areas should get the RAC Global,” says Marcela Saad, RAC, of MarcM Consulting Canada, in Kitchener, Ontario. “I believe that with the world business globalization, professionals are required to expand their knowledge to accommodate not-so-harmonized regulatory requirements. It is necessary to show that your expertise is not restricted to one single region.”
“For Indian colleagues, Global would be an ideal choice,” says Raj Balasubramanian, director, RA/QA, for Elekta Medical Systems India, in Chennai, India. Balasubramanian has the US and EU credentials, and is preparing to take the RAC (Global) exam as his professional focus has shifted to India over the past few years.
The RAC (Global) exam covers the full product lifecycle for medicines and medical technology, as well as international guidelines and standards from the International Conference on Harmonisation (ICH), the International Medical Device Regulators Forum (IMDRF), the now-defunct Global Harmonization Task Force on Medical Devices (GHTF), the World Health Organization (WHO), and the International Organization for Standardization (ISO).
Perhaps the best way to understand what is covered by the RAC (Global) exam—or any of the four exams—is to read the content outline, which can be found in the appendices of the RAC Candidate Guide.
Regardless of which RAC credential you decide to pursue, the global nature of the regulatory profession means that each credential has potential value regardless of where you may be located geographically. Most companies, wherever they are based, are looking to introduce their products in multiple markets around the world. In addition, the critical thinking and analysis skills required to pass each of the exams are broadly applicable. “I think the RAC credential is important for anyone in regulatory as it allows you to understand all aspects of regulatory,” says Veerasingam. The most important thing when deciding which RAC is right for you is matching the credential to your experience and career goals.
Tags: RAC, Regulatory Affairs Certification
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