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 22 January 2015 | By Louise Zornoza,
This content is provided by RegLink News, publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members.
China’s Food and Drug Administration (CFDA) has issued the country’s first Good Supply Practices (GSP) regulations that apply to all Class 1, 2 and 3 medical device distributors, as well as third-party logistics service providers for medical devices.
The GSP regulations establish minimum standards for device procurement, delivery acceptance, storage, sales, transportation and after-sales services. Distributors must implement quality management systems that cover all aspects of the distribution process, such as the quality and training of personnel, cold storage and cold-chain transportation, as well as computer information and recordkeeping.
(CFDA GSP Regulations)
Tags: RegLink, RegLink News, Good Supply Practices, GSP, Distribution
Regulatory Focus newsletters
All the biggest regulatory news and happenings.