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.
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. Any of the four RAC exams (US, EU, CAN or Global) 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.
Posted 23 June 2017 | By Michael Mezher
At the EU Summit in Brussels on Thursday, the European Council backed a procedure to determine where the European Medicines Agency (EMA) will be relocated to following the UK's withdrawal from the EU.
And, while previous reports had indicated the decision on where EMA will end up would be made by October 2017, the procedure adopted by the Council instead calls for a vote by the 27 EU member states, minus the UK (EU27), in November to give more time for member states to discuss the moves.
Following the meeting, European Council President Donald Tusk applauded the adoption of the procedure by the EU27 leaders.
"The quick agreement on this was another confirmation of our unity and determination to reduce the uncertainty caused by Brexit," he said.
Under the procedure, member states can submit proposals to host EMA until 31 July, which the European Commission will assess based on the criteria established by the procedure. In particular, the procedure says potential hosts should be able to provide "appropriate" offices that are near an airport that offers convenient flights from the capitals of the other member states and have adequate multi-lingual schools for the children of agency staff.
Then, following a "political discussion" of the Commission's assessment in October, the EU27 ministers will vote on where EMA will reside going forward at the General Affairs Council meeting in November.
For the vote itself, each of the 27 member states will be able to choose their top three picks to host the agency, with three points going to the first choice, two to the second and one to the third.
If a host fails to secure 14 first choice votes in the first round of voting, the three member states that received the most points will move on to the second round of votes.
In the second round, a simple majority of 14 votes will determine the host. If a majority is not reached, then the two highest scoring proposals will move to a third round of voting which will also be decided by a majority vote. In the case of a tie in the third round, the decision will be made by drawing lots between the third round offers.
European Council
Tags: Brexit, EMA Relocation
Regulatory Focus newsletters
All the biggest regulatory news and happenings.