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. 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.
Posted 11 February 2014 | By Alexander Gaffney, RAC,
Can a string of numbers or letters improve the European regulatory process?
EU regulators are hoping the answer is "yes," and have a plan to put that theory to the test.
In an 11 February 2014 announcement, the European Medicines Agency (EMA) said it is unveiling a new Unique Product Identifier (UPI) system that will apply a unique code to each new medicine the agency receives for review.
The tracking code will reportedly help the agency keep track of applications, improve the efficiency of its review processes, and "help create a unique platform for all pre-authorisation activities."
UPIs will be applied to all new medicines-not existing ones or ones already under review-at the agency, including any seeking orphan designation, scientific advice or pediatric development procedures.
Companies filing an application with EMA will need to submit a registration form to EMA with basic information on the medicine and send it to an EMA email account to receive a UPI.
The form calls for information on:
Thereafter, all interactions with the agency with respect to that medicine will need to reference that UPI.
EMA Statement
Tags: EU
Regulatory Focus newsletters
All the biggest regulatory news and happenings.