RAC Study Group

Dear RMRAS Members:

Each year RMRAS organizes study groups to prepare our members for RAC exams held by the Regulatory Affairs Professionals Society (RAPS).  This year we will be holding a Fall course for the EU RAC exam to be held from October 1st through November 30th.  Please note that the study group is designed to take the RAC test, however many regulatory affairs and quality assurance professionals attend the study groups to further their regulatory knowledge.
 
The EU study groups will meet on Tuesdays beginning August 31th for 10 weeks until November 2, 2009.
 
The hours for the study groups are 6:00 pm - 8:30 pm and will be held at a West Denver location to be determined. There is a $75 fee payable to RMRAS for each study group and is payable at the first class. The fee covers all the materials needed for the study group and includes test information, study guide, past tests and additional information to supplement the study guide. You must pre-register to assure materials are made available.
 
If you are interested in the EU RAC study groups, please email Nanci Dexter with your registration request or specific questions at nancid@ecentral.com before August  25th.   
 
If you want to take the exam, you must sign up for the exam at www.raps.org by 09/08/10.  The fee is $375.00 for RAPS members and $560.00 for nonmembers.
 
RMRAS will be holding classes for the US RAC in the Spring of 2011.
 
Below is some general information about the Regulatory Affairs Certification (RAC).
 
Thanks!
 
Nanci Dexter, RAC (US & EU), CQA, CQIA, CQM
RAC Certification Chair, Treasurer

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About the Regulatory Affairs Certification through the Regulatory Affairs Professionals Society (RAPS).

RAPS provides certification for the healthcare product RA community through its Regulatory Affairs Certification (RAC). The RAC designation is a mark of professional distinction. The RAC is indicative of the professional and technical abilities that are vital in this time of increasing challenges and demands within the health product sector.

Regulatory Affairs Certification (RAC) is a professional distinction that identifies individuals committed to excellence, the pursuit of knowledge and career advancement. The RAC is the only certification available to RA professionals within the healthcare product sector.

To become certified, individuals must pass the RAC examination, offered every year in April and November at worldwide locations. Three different certifications are available: RAC (CAN) for Canadian regulations, RAC (EU) for European regulations and RAC (US) for US regulations.

Currently, more than 3,000 RA professionals have earned the RAC designation, with many of them holding more than one regional credential (Canada, EU or US).

RAC-credentialed professionals are among the current and rising leaders in regulatory affairs in industry, government and academic organizations. It is intended for the regulatory affairs professional with three to five years of regulatory experience.

Why is Certification Desirable?

Certification sets those with the credential apart—or above—those without it. There are a number of advantages to seeking certification. Certification becomes a public recognition of professional achievement—both within and outside of the profession. For many, achieving certification becomes a personal professional goal—a way to test knowledge and to measure it against one’s peers. Others see certification as an aid to career advancement.

Exam Overview

       100 multiple-choice questions for each of the RAC exams

       Two hours to complete each exam

       Administered by computer

       Administered only in English

The RAC Examinations are knowledge-based examinations addressing laws, regulations, policies and guidelines affecting regulated health products, including medical devices, pharmaceuticals, biologics and biotechnology in their respective regions. The examination is reviewed and revised annually.

For a comprehensive description of the RAC examinations, including procedures, format and a content outline visit www.raps.org for more information.