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.
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.
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 28 June 2013 | By Ansis Helmanis,
The Australia New Zealand Therapeutic Products Agency (ANZTPA) has launched an adverse event reporting database, the Joint Adverse Event Notifications System (JAENS), that combines drug and device adverse event reports received by Australia's Therapeutic Goods Administration (TGA) and New Zealand's Medicines and Medical Devices Safety Authority (Medsafe).
Reports come from a wide range of sources, including members of the public, general practitioners, nurses, other health professionals and the therapeutic products industry. JAENS includes two search functions, one for specifically for drugs, and the other for devices
Since June 2011, Australia and New Zealand have been moving towards a joint regulatory scheme for therapeutic products. The two countries anticipate that ANZTPA will replace the TGA and Medsafe in 2016.
JAENS Announcement
Read all Breaking News from RegLink
Tags: New Zealand, australia
Regulatory Focus newsletters
All the biggest regulatory news and happenings.