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 22 January 2016 | By Zachary Brennan
The U.S. Food and Drug Administration (FDA) announced Friday that it is conferring with European regulators, including the European Medicines Agency (EMA) and France's ANSM, after a Phase I trial resulted this week in the death of one enrolled subject and neurological injury to four others.
FDA says no trials have occurred in the US with Bial’s BIA 10-2474, an inhibitor of fatty acid amide hydrolase (FAAH), an enzyme involved in cell function in the nervous system. That double-blind, randomized, placebo-controlled combined single-ascending dose and multiple ascending dose trial, which is currently under French investigation with the help of EMA, was conducted by clinical research organization Biotrial. The trial protocol was released yesterday by French newspaper Le Figaro.
“FAAH inhibitors have been studied for their potential therapeutic use in a number of neurological disorders,” FDA said. “This week’s tragedy in France is the first human fatality following exposure to an FAAH inhibitor.”
FDA also said it is in the process of collecting and reviewing safety information pertinent to FAAH inhibitors under investigation in the US. Janssen announced earlier this week that it would voluntarily suspend an FAAH Phase II trial for mood disorders, though the company has “not received any reports of serious adverse events.”
For its part, FDA will work with sponsors to ensure the safety of participants in clinical studies and take regulatory action as appropriate, and that patients and investigators participating in trials of FAAH inhibitors are fully informed of the risks and potential benefits of these drugs.
The agency also makes clear that Biotrial’s mishap is extremely rare in the US, as trial sponsors must “collect rigorous laboratory and animal data and must submit such safety data to FDA in an IND [investigational new drug] application before any human volunteers may be enrolled in a phase 1 study.” Sponsors also have to wait 30 days after submitting an IND application before Phase I studies can begin so FDA scientists can review the safety data and determine if the proposed study is reasonably safe to proceed.
“Catastrophic adverse events in phase 1 studies conducted in the U.S. are extremely rare,” the agency concluded.
FDA Statement
Tags: Biotrial, Bial, ANSM, EMA, FDA
Regulatory Focus newsletters
All the biggest regulatory news and happenings.