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 04 June 2013 | By Ansis Helmanis,
Australia's Therapeutic Goods Administration has opened a new consultation on proposed guidance regarding the individual (known as the Qualified or Authorised Person) that must certify that a drug has been manufactured according to the requirements of the marketing authorization and cGMPs.
The Australian system is different from the European system of batch release by a Qualified Person, which is why the current PIC/S Guide to Good Manufacturing Practice for Medicinal Products has not been adopted in Australia.
The proposed guidance is specific to Australia's requirements on the release of medicinal products. The proposal also covers investigational medicinal products, and medicines from biological origin, such as vaccines and biotechnology drugs. However, it does not apply to some biologic products, such as those containing or derived from human cells or human plasma.
The deadline for comments is 6 September 2013.
TGA Guidance on Authorised Persons
Read all Breaking News from RegLink
Tags: CGMPs, australia
Regulatory Focus newsletters
All the biggest regulatory news and happenings.