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 01 October 2015 | By Zachary Brennan
The European Medicines Agency’s (EMA’s) Management Board on Thursday nominated Professor Guido Rasi as the executive director of the agency, a little less than a year after he was forced to step down from the position.
Rasi has been invited to give a statement to the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) on 13 October 2015, and the appointment of the new executive director will be made after this session. The EMA told RAPS on Thursday that the short list of candidates for the position is confidential.
The nomination might be a surprise for some as back in November 2014, Rasi was forced to step down by the EU Civil Service Tribunal after adjudicators found that the European Commission had improperly selected him in 2011.
The case against Rasi was filed by Emil Hristov, formerly with the Bulgarian Drug Agency and a member of EMA's board, who maintained that EMA and the European Commission had improperly assembled a short list of candidates for the position of EMA's executive director after the controversial departure of former leader Thomas Lönngren in 2010.
Hristov had applied for the position, but was ranked last among eight candidates and was not selected to be on a "short list" of candidates presented to EMA's Board of Directors. The assembly of that "short list" of candidates by a selection committee was improper, the EU Civil Service Tribunal found, and the EMA board should have considered the candidacy of Hristov.
The EMA later appealed the court’s decision, saying the ruling was not proportional or balanced.
Deputy Executive Director Andreas Pott will continue to lead EMA operations and to legally represent EMA until the new executive director has officially taken up his duties.
The chair of the Management Board, Professor Sir Kent Woods, who previously called the court ruling to remove Rasi regrettable, said Thursday: “The decision of the Management Board is the result of a robust recruitment process over the last months. We look forward to Professor Rasi resuming his leadership of the Agency.”
Rasi added, “Looking to the future, we must continue to meet patients’ legitimate expectations for access to new and safe therapeutic options. This requires that the medicines authorization process not only supports the early stages of research and development, but also strives to make the best possible use of real world data throughout a medicine’s lifecycle.”
EMA Press Release
Tags: Guido Rasi, Sir Kent Woods, EMA, EMA Executive Director
Regulatory Focus newsletters
All the biggest regulatory news and happenings.