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.
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.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
With so many global regulation changes, staying informed is a challenge. Join other regulatory professionals as you navigate the gray together.
For 20 years, our flagship publication, Fundamentals of US Regulatory Affairs, has been giving regulatory professionals the insights and answers they need, right at their fingertips.
There are hundreds of RAC testing centers available worldwide. Either RAC exam (Devices and Drugs) may be taken at any location. Find an upcoming exam at a location near you.
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.
RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.
Posted 03 December 2014 | By Alexander Gaffney, RAC,
The US Senate has passed legislation that would overhaul the Neglected Tropical Disease Priority Review Voucher (PRV) system in the hopes of making it more enticing to pharmaceutical companies, and in particular those developing new treatments for the Ebola virus.
S.2917, the Adding Ebola to the FDA Priority Review Voucher Program Act, passed the US Senate by unanimous consent on 2 December 2013.
"Today the Senate took a strong step to support that mission by passing this bipartisan bill to incentivize the development of Ebola treatments and vaccines," Sen. Tom Harkin (D-IA) said in a statement. Sen. Lamar Alexander (R-TN) said he hoped the bill would "one day help lead to a cure" for Ebola.
For a complete explanation of the Ebola voucher reform bill, please see our explainer article here,
The bill now goes to the US House of Representatives, where an identical piece of legislation, H.R. 5729, was introduced on 18 November 2014 and already enjoys bipartisan support. If passed by the House Energy and Commerce Committee and the full House of Representatives, the bill would then be sent to President Barack Obama, who is expected to sign it.
In a blog post in November 2014, Obama's Ebola czar, Ron Klain, called the bill "encouraging" and said it was a welcomed bipartisan effort against the threat of Ebola.
US Senate Statement
Bill Tracker for S.2917
Tags: Voucher, Ebola, Neglected Tropical Disease Priority Review Voucher, Priority Review Voucher, Tropical Disease Priority Review Voucher, Senate, Legislation, Adding Ebola to the FDA Priority Review Voucher Program Act, Bill
Regulatory Focus newsletters
All the biggest regulatory news and happenings.