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 19 July 2012 | By Alexander Gaffney, RAC
In a change with existing policies, the European Medicines Agency (EMA) announced Thursday, 19 July its plans to make all committee agendas and minutes publicly available by the end of 2013. The move is the latest in a flurry of recent moves by the agency to increase transparency after years of criticism regarding its perceived opaqueness.
EMA coupled its announcement with a "first wave" of documents pertaining to the Paediatric Committee (PDCO). The documents for that committee appear to be in a standardizedformat, making comparisons between them simple.
The documents also contain all conflicts of interest declared by meeting participants, though it remains difficult to determine the extent of some conflicts as a result of potentially confusing topic codes such as EMEA-001033-PIP02-11 or EMEA-000222-PIP01-08-M06.
In a statement posted to EMA's website, Executive Director Guido Rasi, who replaced Thomas Lönngren in November 2011, said the move is "an important part of opening up our operations."
The agency said the release of all minutes will be phased in, with final completion expected by the end of 2013.
Read more:
EMA - European Medicines Agency announces plan to publish committee agendas and minutes
Tags: Scientific Committees, Rasi, Transparency, Latest News
Regulatory Focus newsletters
All the biggest regulatory news and happenings.