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 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.
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.
RAPS Euro Convergence brings regulatory peers from the EU and worldwide together in one forum to gain insights and exchange ideas on the region's most pressing issues. Register today to attend 10-12 May 2021.
Registration is now open for RAPS Convergence 2021! Gather with the regulatory community 12-15 September for four days of learning, engagement, and excitement.
With contributions from more than 30 authors from seven countries, the new edition incorporates a global overview of the field and is designed to help you get the most out of your regulatory intelligence endeavors.
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.
Posted 24 May 2012
BREAKING UPDATE: In a 96-1 vote, the US Senate has passed the Food and Drug Administration Safety and Innovation Act. The bill will now wait to be merged with the House of Representatives' version of the same legislation. Politico has more on this piece of breaking news.
------------------------------------
After multiple days of political wrangling and an unexpectedly large number of amendments, the Food and Drug Administration Safety and Innovation Act(FDASIA) is finally scheduled to be voted on during a Thursday, 24 May session of the US Senate.
The vote had originally been scheduled for Wednesday, but was repeatedly pushed back in the face of dozens of amendments being offered by various Senators-some of which were entirely unrelated to the legislation.
After Senate Majority Leader Harry Reid threatened to table the bill entirely if amendments were not withdrawn, the list of 39 proposed amendments was eventually whittled down to just 11.
Those amendments and their general topics are as follows:
The bill is set to be voted on at 2:00 pm on 24 May, with an agreement in place to suspend all debate at that time.
The Hill reports some of the more controversial provisions of the bill, including a proposal by Sen. David Vitter (R-LA) to attach a National Flood Insurance reauthorization bill and a proposal by various senators to kill an impending excise tax on medical devices, have been removed in the interest of keeping the bill as un-controversial as possible.
Read more:
Senate Floor Schedule for Thursday, May 24, 2012
The Hill - Reid says Senate is waiting on Republicans on FDA amendments
Tags: Device Tax, Amendments, Reid, FDASIA, Delay, User Fee, MDUFA, Latest News, Senate, GDUFA, PDUFA
Regulatory Focus newsletters
All the biggest regulatory news and happenings.