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 12 April 2012 | By Alexander Gaffney, RAC
A new proposal being advanced by India's Planning Commission would allow private, third-party auditors from specially trained companies to inspect pharmaceutical manufacturers and issue certificates of compliance, reports Wall Street Journal subsidiary Live Mint.
The proposal would likely be phased in, with traditional medicines being audited for some time before modern pharmaceutical manufacturers would be allowed to participate, said a source interviewed by Live Mint.
The proposal could ease pressures on the Central Drugs Standard Control Organization (CDSCO), which has been experiencing regulatory capacity issues as a result of a shortage of funding.
CDSCO and other regulatory bodies will still retain the right to inspect all manufacturing facilities for any valid reason, reports Live Mint.
Live Mint - Govt may allow third-party audits for drug quality
Regulatory Focus - Report: India Boosting Ability to Regulate Clinical Trials
Read all Regulatory Focus news stories on India.
Tags: Regulator, Regulatory Capacity, Latest News, pharmaceutical, drug, regulatory
Regulatory Focus newsletters
All the biggest regulatory news and happenings.