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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.
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.
Download your copy of the new events calendar and see all the online workshops, conferences, RAC exams and European online workshops RAPS has planned for 2021 at a glance.
Registration is now open for RAPS Euro Convergence 2021! Attend to join peers from EU and around the world to gain insights and exchange ideas on the regions most pressing issues.
An invaluable resource for any professional engaged in designing, composing, compiling, or commenting on regulatory documentation
From self-assessments to help you identify your strengths and areas to focus on to reference books and online courses that will help you fill in the gaps in your regulatory knowledge, RAPS has the resources to help you prepare for the RAC exam.
The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products.
RAPS offers universities and students discounts on RAPS publications and access to regulatory news, information and networking. Find out more below.
The Fundamentals of Regulatory Affairs series books are used by more than a dozen universities as a required text, some of the largest healthcare organizations as a staple in each employee’s office and by Regulatory Affairs Certification (RAC) exam takers as a key study tool.
The series is available in US, EU, Canada, Japan and International editions. Also available are the Global Medical Device Regulations and the Global Pharmaceutical & Biologics Regulations books—a compilation of chapters covering medical device or pharma/bio regulation, adapted from the five books in RAPS’ Fundamentals of Regulatory Affairs series.
Available Titles
Desk Copies
Desk copies are available for RAPS published books that are assigned as primary (as opposed to recommended) text in a scheduled course for the current or following term. A complimentary copy will be provided to universities with the understanding that 10 or more copies of the book will be purchased for their students.
If you are considering a book for potential course adoption, please see below for instructions on requesting an examination copy.
Examination Copies
Examination copies are sent to teaching faculty who would like to review a book before deciding whether to use it in a course. RAPS will provide an examination copy of any RAPS published book you wish to consider for course use at a 50% discount (off the nonmember rate), shipping charges apply. You will then have 60 days to:
To request an examination copy, please email Jill Yager and provide your name, shipping address, email, phone number, course title, expected enrollment, semester or quarter in which the course will be offered and course level (undergraduate or graduate).
Start driving regulatory excellence before you’ve graduated with a Student Membership to RAPS. You’ll have access to unparalleled resources and benefits to build your resume, develop leadership skills and network with established professionals. Student members receive:
RAPS student members also receive:
Available Titles for Student Bundles:*
*E-book also available.
Explore Degree and Certificate Programs. Student Membership Eligibility Student membership is available to any individual enrolled as a full-time undergraduate or graduate student at an accredited higher education institution. A school verification form confirming your full-time student status may be requested during your membership term. RAPS reserves the right to decline membership in the event that documentation of full time student status is not provided upon request.