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.
Share your knowledge and expertise with your regulatory peers by submitting an in-depth, evidence-based article focusing on key areas and emerging issues in the global regulatory landscape.
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.
RAPS Euro Convergence brings regulatory peers from the EU and worldwide together in one forum to gain insights and exchange ideas on the region's most pressing issues. Register today to attend 10-12 May 2021.
Registration is now open for RAPS Convergence 2021! Gather with the regulatory community 12-15 September for four days of learning, engagement, and excitement.
With contributions from more than 30 authors from seven countries, the new edition incorporates a global overview of the field and is designed to help you get the most out of your regulatory intelligence endeavors.
Regipedia is an interactive resource created to benefit RAPS members with 24/7 access to more than 2,300 regulatory terms.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 12 April 2012
An Arkansas judge slammed Johnson & Johnson (J&J), the parent company of subsidiary Janssen Pharmaceuticals, with a $1.2 billion dollar fine after Janssen was found to have engaged in deceptive marketing practices for its drug Risperdal, reports The New York Times.
Not only is the fine one of the largest monetary penalties ever levied upon a drug company, reports The Times, but it also opens the door for many subsequent lawsuits.
"Most attorneys general can do the math, and there's no reason for any state to settle if they can win really big numbers in court," said Patrick Burns of the group Taxpayers Against Fraud, to The Times.
While J&J said it planned to appeal the decision, the company is still facing similar lawsuits in a number of states. The Arkansas case only reflected the company's violations of Arkansas state Medicaid law-240,000 violations in all, reports The Times.
The lawsuits stem from what prosecutors describe as deceptive marketing of J&J's drug Risperdal, then marketed by Janssen.
"Prosecutors have accused J&J and Janssen of hiding the risks associated with Risperdal, which is approved to treat schizophrenia, bipolar disorder and behavior problems in teenagers and children with autism," explained The Times.
"These two companies put profits before people, and they are rightfully being held responsible for their actions," Arkansas Attorney General Dustin McDaniel said in a statement.
Read more:
The New York Times - J.&J. Fined $1.2 Billion in Drug Case
Pharma Times - J&J slapped with $1.1bn fine for deceptive Risperdal advertising
Bloomberg - J&J's Marketing of Risperdal Violated Law, Arkansas Jury Rules
Tags: $JNJ, Arkansas, Risperdal, Janssen, Lawsuit, Fine, Johnson & Johnson, Latest News, pharmaceutical, marketing, drug
Regulatory Focus newsletters
All the biggest regulatory news and happenings.