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 20 October 2015 | By Zachary Brennan
The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) will look to better leverage big data and advance the use of patient-reported outcomes in regulatory decision making, according to a top 10 list of regulatory science priorities released on Tuesday.
The release of the list coincides with the overarching goal of CDRH regulatory science, which is to help develop and apply tools, standards and methodologies to study the safety, effectiveness, performance and quality of devices.
While serving as a way to help CDRH make strategic research funding decisions to ensure that the division's research is focused on the issues, gaps and needs relevant to the regulatory science of medical devices and radiation-emitting products, the list includes:
Safety has always been a top priority for CDRH, though the report notes that there is "a gap in the availability of tools and methodologies to assess the impact of various materials and material types on the quality, performance and safety of medical devices, particularly when trying to predict long-term clinical outcomes."
Among other things, CDRH will look to new methodologies and tools that more accurately predict the clinical impact of surface coatings, materials corrosion and additive manufacturing on device quality, performance and safety. In addition, CDRH will promote the development of alternative materials and look to increase the safety of the design of devices.
The center also calls for more research to understand how to enhance the performance and security of medical devices, and to understand the impact of software modifications on device performance.
The Regulatory Science Subcommittee (RSS) of the CDRH Center Science Council, which was created in 2013, developed the priorities and needs assessments based on collections made by the RSS across all CDRH offices.
CDRH explains that the list was created to help assess the needs and gaps in regulatory science and that it's intended to be proactive and anticipatory, while being responsive to emerging public health issues.
CDRH Regulatory Science Priorities Report
Tags: CDRH, FDA, regulatory science, device cybersecurity, device safety
Regulatory Focus newsletters
All the biggest regulatory news and happenings.