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.
With so many global regulation changes, staying informed is a challenge. Join other regulatory professionals as you navigate the gray 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. Either RAC exam (Devices and Drugs) 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.
RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.
Posted 10 April 2015 | By Michael Mezher
A legal battle in Germany to determine responsibility in the aftermath of the Poly Implant Prothese (PIP) breast implant scandal will be put on hold while a German court asks for clarification from the European Court of Justice (ECJ), Deutsche Welle reports.
For many years, PIP was one of the largest producers of silicone breast implants. However, after it came to light that the company used industrial-grade silicone in its implants, the company shut down after it was sued in several countries and its owner sentenced to prison. At the same time, health authorities scrambled to determine a course of action, which ranged from careful monitoring to recommending the implants be preemptively removed.
In several of the suits, the plaintiffs also pointed to TÜV Rheinland, a notified body based in Germany. Plaintiffs claimed the company was negligent in its duties to certify PIP's quality management system (QMS) and design dossier for the implants.
In 2013, a French court found TÜV liable for failing to perform its duties for not identifying that the silicone used was not authorized for use in the implants, and ordered the company to pay compensation to the 1,700 women represented in the case. The following year, the Court of Appeals of Aix-en-Provence rejected an appeal by TÜV to reverse the decision.
Because PIP is no longer in business, plaintiffs have had to look elsewhere for compensation. TÜV says it is facing roughly 10 suits related to the implants and has claimed it performed its required duties and should not be held liable for fraud committed by a company it reviewed.
The plaintiff in one of these cases is seeking €40,000 in compensation for having her PIP implants removed in 2012, saying TÜV should not have certified the implants as safe. Her case reached Germany's Federal Supreme Court on appeal after being rejected twice by lower courts.
Now the case has been put on hold while the German court awaits clarification on several points of law from the ECJ. The Judge for the German court has said, "The critical question is what monitoring and supervisory controls TÜV had."
The ECJ's advice is likely to impact the ruling in the case and could potentially affect the other outstanding suits against TÜV.
Deutsche Welle
Tags: PIP, Poly Implant Prothese, breast implants, TÜV, notified body, European Court of Justice
Regulatory Focus newsletters
All the biggest regulatory news and happenings.