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 09 January 2018 | By Zachary Brennan
Medical device companies should want to streamline the process of getting their products reviewed simultaneously by the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Centers for Medicare and Medicaid Services (CMS) - so why aren’t they?
Jeff Shuren, director of CDRH late Monday told attendees of JP Morgan’s annual conference that he thinks fear and a limited amount of CMS staff are two reasons that the parallel review program has not taken off as well as hoped.
"What you’re seeing publicly is a lot less than what’s actually happening," Shuren said, calling on companies to engage with FDA and CMS "early and often."
The comments come as just two products have successfully navigated an FDA and CMS parallel review and as an FDA spokesperson told Focus that the agency has received about 60 inquiries from device makers about the parallel review program and received 26 applications to participate.
As far his two reasons for the slow movement in the parallel review program helping companies, Shuren noted that companies can be afraid about what might be said in such preliminary discussions and that "CMS has much more limited bandwidth [than FDA] to do this and do this well."
Tamara Syrek Jensen, director of the coverage and analysis group at CMS tried to reassure companies that they can seek out advice without making anything official.
"There’s an MOU [memorandum of understanding] between FDA and CMS – if anyone wants to come talk to both of the agencies, they can do that now," Jensen said. "Start the conversation, give us a call."
Tags: parallel review, Shuren, MOU
Regulatory Focus newsletters
All the biggest regulatory news and happenings.