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 firstname.lastname@example.org if you need assistance.
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.
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.
Posted 30 December 2011 | By Alexander Gaffney, RAC
Health Canada (HC) released a new guidance document on Thursday that clarifies the Medical Devices Regulations' mandatory problem reporting for medical devices.
The guidance document aims to conform to the harmonized approach set forth by the Global Harmonization task force in N54 - Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices.
HC also released an updated medical device problem reporting form along with the guidance.
(Health Canada - MPR Guidance for Industry)
(Health Canada - MPR Reporting Form)
Tags: Mandatory Problem Reporting, Guidance for Industry, Latest News, guidance, medical device
Regulatory Focus newsletters
All the biggest regulatory news and happenings.