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 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.
Download your copy of the new events calendar and see all the online workshops, conferences, RAC exams and European online workshops RAPS has planned for 2021 at a glance.
Registration is now open for RAPS Euro Convergence 2021! Attend to join peers from EU and around the world to gain insights and exchange ideas on the regions most pressing issues.
An invaluable resource for any professional engaged in designing, composing, compiling, or commenting on regulatory documentation
From self-assessments to help you identify your strengths and areas to focus on to reference books and online courses that will help you fill in the gaps in your regulatory knowledge, RAPS has the resources to help you prepare for the RAC exam.
Posted 08 February 2013 | By Alexander Gaffney, RAC,
The European Medicines Agency (EMA) has announced that it has started a safety review of Diane 35 (cyproterone acetage 2mg, ethinylestradiol 35µg), a hormone-regulating drug commonly indicated for birth control or acne, in response to French regulators' concerns that patients are at an unacceptably high risk of developing venous and arterial thromboembolism (VTE/ATE).
The drug, as well as its generics, came to the attention of regulators in recent months after French regulator ANSM received reports that as many as four women had died after taking the drug, all having suffered from blood clots. Those risks, inherent in many third- and fourth-generation contraceptives, have long been known to regulators. In France, for example, the drug has been prescribed for more than 20 years.
But Diane 35 and its generics suffer from one regulatory lapse in oversight: They have never been centrally evaluated.
"These medicines have been authorised at the level of individual Member States for many years," EMA explained. "They are widely used across Europe. However, their authorised uses differ between Member States."
In some countries, they are indicated for contraceptive use; in others just for hormone-related contraceptive use. In France, Diane 35 is indicated only for the treatment of acne, though regulators have told EMA the drug is widely used off-label as well.
So now, after French officials conducted a months-long investigation into the product culminating in them asking EMA to conduct an EU-wide investigation, the relatively new Pharmacovigilance Risk Assessment Committee (PRAC) has agreed to investigate the products.
That investigation is set to wrap up in May 2013, when PRAC said it is likely to adopt a recommendation.
This is the first time the PRAC had been asked to conduct a review by a member state under the new pharmacovigilance legislation, EMA said in previous statement.
EMA said patients currently taking the drug should not stop taking it without first consulting with their respective physicians.
Regulatory Focus newsletters
All the biggest regulatory news and happenings.