• RAPS' LatestRAPS' Latest

    How to Schedule Your RAC Exam

    One simple but important step in your quest for Regulatory Affairs Certification (RAC) is scheduling your exam. The four RAC exams are computer-based and are offered at testing centers around the world during the April–May and October–November exam periods, so regardless of which exam you wish to take, there will be a number of possible locations and dates available. Once you have registered for the exam of your choice, about 15 days before the exam c...
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    RAC Eligibility Explained

    If you are considering taking one of the four Regulatory Affairs Certification (RAC) exams, one of the first things you need to do is determine whether you meet the exam eligibility requirements . The criteria are not complicated, but since they were changed—the updated criteria went into effect beginning with the autumn 2014 exam period—there may be some lingering confusion over the exact requirements. To be eligible to take the RAC exam, you must have at least a bac...
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    The Four RAC Credentials Explained

    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 RAC Credentia...
  • Regulatory NewsRegulatory News

    Anvisa Updates BA, BE Test Best Practices Certification

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. Brazilian regulator Anvisa has released an updated Certification of Good Practice for the conduct of bioavailability/bioequivalence (BA/BE) studies.  The practices are those that must be adopted by research centers in order to ensure their BA/BE studies—comparing pharma...
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    New RAC Eligibility Requirements, Deadlines, Application Fees Coming in 2014

    The Regulatory Affairs Certification Board (RACB) has approved a number of changes to the policies governing Regulatory Affairs Certification (RAC) that will go into effect in 2014. The changes affect both those taking an RAC exam for certification and those who have already been certified and wish to maintain their RAC credential in good standing. New Eligibility Requirements The most significant change is to the eligibility requirements for candidates seeking the cre...
  • Brazil Suspends Certification Process for Foreign Bioequivalence and Bioavailability Test Centers

    Brazil's National Agency for Sanitary Surveillance (Anvisa) has suspended processing of new applications for primary certification of bioavailability or bioequivalence for medical products by research centers located outside the country. Applications filed prior to 31 July 2013, the date the suspension entered into force (RDC 37/13), will still be processed, regulators said. The purpose of the suspension is to facilitate the review of existing rules governing foreig...
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    RAC-exam Prep Webcast Presenters Give Advice for RAC Exam Takers

    Passing the Regulatory Affairs Certification (RAC) exam can be a significant milestone in your regulatory career. The RAC is the only post-academic professional certification specifically for healthcare product regulatory professionals, and in the 22 years since it was first introduced, it has developed a reputation as a respected and important credential in the field. Why Get the RAC? While regulatory experience is almost certainly the most important factor employers...
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    Why Get Regulatory Affairs Certification? Ask Those Who Have It

    As a regulatory professional, you may be considering Regulatory Affairs Certification (RAC) as a way to distinguish yourself, demonstrate your regulatory knowledge and skills, advance your career or even as a tool to help you expand and sharpen your grasp of regulatory issues and critical thinking skills. After all, the RAC is the only post-academic professional certification specifically for healthcare product regulatory professionals. But what do those who have the cre...
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    RAPS Announces Spring 2012 Class of RACs

    • 31 August 2012
    The Regulatory Affairs Professionals Society has announced the names of the 203 individuals who earned their Regulatory Affairs Certification during the spring 2012 RAC exam period. Along with the Regulatory Affairs Certification Board, RAPS extends sincere congratulations to these accomplished professionals. Following is the full list of the spring 2012 RAC class. RAC Canada Bradley Abbott Purvi Agrawal Nicholas Allard Maha...
  • EMA Launches Mandatory Training Course to Help MAHs Comply with EudraVigilance Regulations

    A new course launched by the European Medicines Agency (EMA) aims to assist Marketing Authorization Holders (MAHs) comply with new Article 57(2) EudraVigilance regulations on the submission of information on medicines. The six-part course covers the basics of the EudraVigilance system, the regulatory underpinnings of the system, which definitions are used in the system, the submission of EudraVigilance Product Report Messages and how to enter data. Successful completion...
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    Autumn 2011 RAC Class

    The Regulatory Affairs Certification Board and the Regulatory Affairs Professionals Society extend sincere congratulations to the 279 individuals who earned their Regulatory Affairs Certification during the Autumn 2011 RAC exam period. Following is the full list of the Autumn 2011 RAC class. RAC Canada Olufemi Adeoye Yverre Bobay Joanna Chan Nancy Gertlar Babak Givehchi Pantea Habibnia ...
  • Brazil's Anvisa Introduces Additional Controls on Breast Implant Products

    Brazilian regulatory authority Anvisa this week became the latest health regulator to exercise greater enforcement controls over the sale and testing of breast implant products in the wake of a global scandal, reports Reuters . "Health regulator Anvisa will require implants to be certified through the national quality control institute Inmetro to ensure products meet new criteria including physical strength, tear resistance and absence of toxic substances," wrote Reute...