RAPS announced today that 214 individuals earned Regulatory Affairs Certification
(RAC) during the most recent RAC exam period, this past spring. Of that group, 59 passed one of two new variations of the RAC exam designed to test knowledge of regulations pertaining to either pharmaceuticals or medical devices, specifically.
The RAC exams cover knowledge of healthcare product regulations, critical thinking and analytical skills that regulatory professionals with three to five years of experience are expected to have mastered. Earning the RAC credential indicates knowledge of relevant regulations as well as the ability to apply them in a variety of real-world scenarios.
First established nearly 30 years ago, the RAC is the only professional credential specifically for the healthcare product regulatory field. Last year in response to demand from the regulatory community, RAPS announced the launch of two new RACs
focused on specific product areas—one for drugs and one for devices. The four legacy exams, which cover regulations for both drugs and devices but focus on a particular region—RAC US, EU or Canada—or international standards—RAC Global—continue to be offered this year but will be discontinued after the upcoming autumn exam period.
“We have been hearing calls for years from regulatory professionals, who work with medical devices or drug products exclusively, for RAC exams that more closely reflect their everyday work and don’t require learning a whole new industry’s worth of regulations,” said RAPS Executive Director Paul Brooks. “The transition from region-based to product-based exams hasn’t been without challenges, but the response to the RAC Drugs and RAC Devices has been overwhelmingly positive. The Regulatory Affairs Certification Board, which oversees the exams, worked diligently to ensure all exams require a similar level of expertise, so regardless of the specific exam passed, all RAC-holders should be equally proud of their achievement.”
In addition to passing an exam, RAC holders must recertify every three years through continuous learning, professional development and regulatory leadership activities, demonstrating their ongoing commitment to the profession. Currently, there are more than 4,700 RAC-credentialed professionals around the world.
The next RAC exam period will be this autumn. Exams will be administered at locations around the world from 21 October to 30 November. Registration is now open for all exams. The deadline to apply is 24 September
. For more information, visit RAPS.org/rac
Following is the complete list of those who earned the RAC credential in spring 2019:
Ming Yi Chang
Sergio De Del Castillo
Suresh Kumar Gorentla Venkata
Mabel Ng Li Ling
Leilane Yumi Oshiro Gaglianone
Byron Ray Griffith
Ze Hong Chew
Nadia Katherine Fuel Crespo Pottier
Diana Hernandez Bounina
Jadz Jevz Lee
Anisha Shreepad Panth
Emily Nelson Deleon
Latonya Dawn Green
Seung Hun Lee
Chen Jung Lee
Sorcha Mc Ginty
John Gavin Mccullough
Lilia Nunez Rodriguez
Vinayak Shankar Rajana
Muralidhara Reddy Sathi
Leonard S. Smith
Alicia Staz, M.S., Cqa
Alakananda Devi Vadlamudi