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. 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.
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 09 June 2017 | By Zachary Brennan
The European Medicines Agency’s (EMA’s) Pharmacovigilance Risk Assessment Committee (PRAC) will hold its first public hearing on 26 September 2017 to discuss the safety of using valproate-containing medicines in the treatment of various conditions for women and girls who are pregnant or of childbearing age.
The public element of the meeting means EU citizens will be invited to share their experiences with these medicines, which are approved nationally in the EU to treat epilepsy, bipolar disorder and in some countries, migraines, according to EMA.
In 2013, the US Food and Drug Administration (FDA) advised health professionals and women that the anti-seizure medication valproate sodium and related products, valproic acid and divalproex sodium, "are contraindicated and should not be taken by pregnant women for the prevention of migraine headaches. Based on information from a recent study, there is evidence that these medications can cause decreased IQ scores in children whose mothers took them while pregnant."
The European regulator said Friday that a list of specific questions for the public, a summary of safety concerns and information on how to participate will be published at the beginning of July.
The decision to hold the meeting follows the adoption of rules of procedure on the organization and conduct of public hearings and a simulation training in 2016.
Also on Friday, EMA announced that PRAC has concluded that there is no evidence of a change in the known risk of neutropenic enterocolitis after treatment with docetaxel, a cancer medicine.
Tags: valproate, pregnant women, PRAC
Regulatory Focus newsletters
All the biggest regulatory news and happenings.