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 firstname.lastname@example.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.
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 11 May 2012 | By Alexander Gaffney, RAC
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has released an updated version of its Efficacy (E) 14 Guideline, providing four new pieces of insight on the clinical evaluation of non-antiarrhythmic drugs.
ICH's Q&A document for E14 - The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs was originally released under Step 4 of the ICH process on 4 June 2008.
The guideline describes how to evaluate the QT/QTC intervals and proarrhythmic potential of patients being given non-antiarrhythmic drugs, which can be used to sudden cardiac deaths.
On 5 April 2012, ICH's Steering Committee approved four additional revisions to the document, which covers the use of different sexes in clinical trials, the use of new technologies in clinical trials, approaches to evaluating QT intervals in late-stage development, and correcting submissions using "Fridericia's and Bazett's correction."
E14 - The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
ICH - Efficacy Guidelines
Tags: Revised, Revision, E14, Heart, harmonization, Latest News, guideline, study, clinical trials
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 ...