Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
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.
Resources, news and special offers to support you and your professional development during this difficult time.
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 site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move across top level links and expand / close menus in sub levels. Up and Down arrows will open main level menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab will move on to the next part of the site rather than go through menu items.
Posted 29 December 2011 | By Alexander Gaffney, RAC
The US Food and Drug Administration (FDA) announced Wednesday that it is working with healthcare providers, manufacturers, standard-setting organizations and government agencies to "reduce the risk of infection from the inadequate reprocessing of medical devices intended for repeat use."
The FDA noted that it has received reports of patients being exposed to biological products as a result of inadequate sterilization after use. However, FDA also noted that transmission of infection as a result of these biological products-including blood, tissue, and body fluids-was extremely rare.
The deputy director of the Center for Devices and Radiological Health (CDRH), Bill Maisel, M.D., said that the benefits of using such devices far outweigh the low risk of acquiring an infection.
Patients are advised to ask their healthcare providers about precautions taken to promote the sterility of their products. FDA is further working with manufacturers and providers to promote clearer instruction manuals for repeat-use devices and generate best-practices for sterilization.
The FDA is making information available to consumers, providers and manufacturers at a new web page devoted solely to the issue.
Tags: Repeat Use, Sterilization, Latest News, Transmission, safety
Regulatory Focus newsletters
All the biggest regulatory news and happenings.