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 email@example.com 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.
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.
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. Any of the four RAC exams (US, EU, CAN or Global) may be taken at any location. Find an upcoming exam at a location near you.
Posted 28 June 2012 | By Alexander Gaffney, RAC
The European Medicines Agency (EMA) has released two separate standard operating procedures covering, respectively, Article 29 procedures under the Paediatric Regulation (No. 1901/2006) and Article 107 procedures relating to Pharmacovigilance measures (Directive 2001/83/EC).
The SOPs, released 27 June, are specifically intended for EMA staff and outline how they are to adhere to the two procedures. Both documents should be useful for regulatory professionals as well, as they provide flow-charts describing the path of a product submission and a pharmacovigilance report through the agency in a step-by-step process.
Both documents are in effect until June 2015, after which time they will be reviewed again by the agency.
EMA - Standard operating procedure: Article 107 procedures - Pharmacovigilance urgent measures
EMA - Standard operating procedure: Article 29 procedures according to the Paediatric Regulation No 1901/2006
Tags: Paeiatric, Pediatric, Latest News, SOPs, pharmacovigilance
Regulatory Focus newsletters
All the biggest regulatory news and happenings.
This article provides a variety of websites with important information on recent changes to FDA guidances and tables ...