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 04 April 2012 | By Alexander Gaffney, RAC
The European Medicines Agency (EMA) announced it will, effective immediately, be tightening its conflict-on-interest policies for scientific experts and members of advisory committees.
The policy was announced 3 April after being endorsed by EMA's Management Board on 22 March 2012.
"The updated policy gives clearer guidance on the involvement of experts in academic trials and publicly funded research," explained EMA in a statement. "It aligns restrictions for the different roles in the scientific decision-making process and tightens the rules on grants from the pharmaceutical industry."
Along with the new standards, EMA also announced a new 11-step procedure on "suspected breaches of trust" for incomplete or incorrect declarations of interest and a new policy for conflicts of interest among Management Board members.
EMA - European Medicines Agency tightens conflicts-of-interests policies with immediate effect
European Medicines Agency policy on the handling of conflicts of interests of the Management Board
European Medicines Agency policy on the handling of conflicts of interests of scientific committee members and experts
European Medicines Agency breach of trust procedure on conflicts of interests for scientific committee members and experts
Public declaration of interests and confidentiality undertaking of European Medicines Agency Management Board
Tags: Scientific Experts, Policies, Conflict-of-Interest, Management Board, COI, Procedure, Conflict of Interest, Latest News, disclosure
Regulatory Focus newsletters
All the biggest regulatory news and happenings.
This article provides a variety of websites with important information on recent changes to FDA guidances and tables ...