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 23 May 2012 | By Alexander Gaffney, RAC
The US Food and Drug Administration (FDA) announced three new advisory committee meetings and a new workshop in the Federal Register on 23 May 2012. Regulatory Focus is pleased to present you with a brief summary of their respective topics.
Meeting: Oncologic Drugs Advisory Committee
The committee will discuss and provide general advice on the extent to which, if any, the pre-surgical identification of clear cell carcinoma of the kidney using an imaging test provides useful clinical information.
Meeting: Risk Communication Advisory Committee
This meeting will discuss how patients perceive, communicate and understand risk when they are facing multiple risks.
Meeting: Requirements for Importing FDA Regulated Products into the US
This meeting will discuss FDA regulations with respect to importing pharmaceutical products, medical devices and other technologies into the US, and the involvement of brokers and forwarders in the importation process.
Public Workshop: Use of Computer Simulation of the US Blood Supply in Support of Planning for Emergency Preparedness and Medical Countermeasures
This workshop aims to discuss the possible applications of an FDA computer simulation model of the US' blood supply during an emergency, the weaknesses and strengths of the model, how to enhance the model, and the development of plausible scenarios to test the model.
Tags: Meeting, Latest News, workshop
Regulatory Focus newsletters
All the biggest regulatory news and happenings.