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.
Resources, news and special offers to support you and your professional development during this difficult time.
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.
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 23 March 2012 | By Alexander Gaffney, RAC
An article in The British Medical Journal (BMJ) claims the US Food and Drug Administration (FDA) approved a higher-dose version of Eisai's blockbuster Alzheimer's drug Aricept 23 (donepezil) despite the concerns of its reviewers at FDA, reports The New York Times.
FDA review staff noted their concerns about the drug's safety and efficacy, according to The Times, finding little evidence of the drug's effectiveness in a 1,400-person clinical trial, but finding a substantial increase in side effects.
Despite recommendations from a clinical reviewer and statistical review at FDA, Aricept 23 was ultimately approved by the Director of FDA's neurology products division, Dr. Russell Katz in July 2010.
The choice was not one that benefited patients, argued Dr. Steven Woloshin, the BMJ article's author.
"It doesn't really have much benefit, but does substantially more harm," said Woloshin.
Sidney Wolfe of the group Public Citizen Agreed with Woloshin's assessment.
"Rarely do we see such a dangerous difference between what pretty much everyone in the neurological division thought and what its leader thought," said Wolfe. "That's a huge slap in the face to all the people who spent much more time reviewing this drug than he did."
Read more:
New York Times - Drug Dosage Was Approved Despite Warning
BMJ - How the FDA forgot the evidence: the case of donepezil 23 mg
Tags: Neurology Products Division, Woloshin, Wolfe, Katz, Alzheimer's, Donepezil, Aricept, BMJ, Latest News, staff, review
Regulatory Focus newsletters
All the biggest regulatory news and happenings.