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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
Share your knowledge and expertise with your regulatory peers by submitting an in-depth, evidence-based article focusing on key areas and emerging issues in the global regulatory landscape.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Registration is now open for RAPS Convergence 2021! Gather with the regulatory community 12-15 September for four days of learning, engagement, and excitement.
Keep the sparks coming! Delegates of the conference have access to on-demand content until the end of October 2021.
This updated edition is a great reference for anyone working in multinational product development and marketing.
Regipedia is an interactive resource created to benefit RAPS members with 24/7 access to more than 2,300 regulatory terms.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory Affairs Certification (RAC), is the leading post-academic professional credential for regulatory professionals in the healthcare product sector. It is intended for individuals employed in regulatory agencies, industry, consultancies and other settings involved with the regulation of healthcare products. Regulatory Affairs Certification tests expertise in two sectors, pharmaceuticals and medical devices, and candidates may choose whether to take the RAC Drugs exam or the RAC Devices exam. All candidates who pass an RAC exam will be equally recognized by the RAC program and will be eligible to put ‘RAC’ after their name.
The Regulatory Affairs Certification Board (RACB) oversees the development of the RAC examinations. Each examination is developed by an examination committee comprised of practicing regulatory experts knowledgeable about the relevant regulations for the region.
The RAC examinations are based on job analysis studies undertaken by the RAC program. These studies are guided by experts in testing and measurement. The job analysis studies are completed before an examination is created and repeated as needed to determine whether there are changes in the role and scope of practice of regulatory professionals that would require adjustment of the examination content. The job analysis study is used to develop the content outline for each examination and determine the number and type of questions to be included in each content area.
Questions on the examinations are updated every year to reflect current regulations, guidelines and practice. New examination content is added for the Spring testing cycle and covers regulations in effect as of 31 December of the previous year.