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 email@example.com 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 18 November 2014 | By Stewart EisenhartEmergo Group
Content provided by Emergo Group, a medical device regulatory affairs and quality assurance consulting firm with offices worldwide.
Brazilian medical device regulator ANVISA has begun accepting feedback from medical device companies subject to quality management inspections in order to improve and standardize inspection processes.
Firms inspected for Brazilian Good Manufacturing Practice (BGMP) compliance now have the option of submitting a form to ANVISA providing their perspective on how their quality system inspections went, and what could be improved.
For the time being, the evaluation program is meant only for investigational purposes, but does perhaps show willingness by Brazilian regulators to take more industry feedback into consideration during the BGMP inspection process over the longer term.
Learn more about Brazilian registration and BGMP compliance here.
Original Post: Emergo Group
Related Post: Brazil relaxes BGMP requirements for manufacturers holding INMETRO certification
Related Post: New Regulation in Brazil Changes Enforcement of BGMP Requirements for Certain Medical Devices
Categories: Regulatory News
Regulatory Focus newsletters
All the biggest regulatory news and happenings.