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 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.
Share your knowledge and expertise with your regulatory peers by submitting an in-depth, evidence-based article focusing on key areas and emerging issues in the global regulatory landscape.
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.
RAPS Euro Convergence brings regulatory peers from the EU and worldwide together in one forum to gain insights and exchange ideas on the region's most pressing issues. Register today to attend 10-12 May 2021.
Registration is now open for RAPS Convergence 2021! Gather with the regulatory community 12-15 September for four days of learning, engagement, and excitement.
With contributions from more than 30 authors from seven countries, the new edition incorporates a global overview of the field and is designed to help you get the most out of your regulatory intelligence endeavors.
Regipedia is an interactive resource created to benefit RAPS members with 24/7 access to more than 2,300 regulatory terms.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 05 February 2014 | By Alexander Gaffney, RAC,
The commissioner of the US Food and Drug Administration (FDA), Margaret Hamburg, is at long last headed to India.
The long-planned trip will reportedly focus on strengthening regulatory ties between FDA and the region's regulators, the Union Health Ministry and the Central Drug Standards Control Organization (CDSCO). The former is similar to the US Department of Health and Human Services (DHHS), while the latter is similar to FDA. India also has local regulatory departments in many of its federal states.
"The FDA's ongoing engagement with our regulatory counterparts in India is critical to our ability to effectively promote the health and safety of American and Indian consumers," Hamburg said in a prepared statement. "I look forward to enhancing our existing relationship and identifying additional opportunities for collaboration."
According to FDA, Hamburg's visit will include visits to Delhi, Cochin and Mumbai, where she will meet with regulators, legislators and policy officials involved in healthcare product and food regulation.
The meeting comes at a somewhat awkward time for both Hamburg and India.
The US and India have been embroiled in a fierce diplomatic imbroglio over the last few months after US law enforcement officials arrested and allegedly strip-searched an Indian diplomat on charges of under-paying one of her employees. The matter reportedly delayed Hamburg's trip by at least several weeks.
For India, Hamburg's trip comes just as regulatory scrutiny of the country's pharmaceutical manufacturing operations is at its highest. As Regulatory Focus has reported, FDA inspectors have found troubling patterns of data falsification at many of the country's top companies, leaving some subject to consent decrees and import alerts.
The subject will reportedly be a target for discussion. "Commissioner Hamburg will … meet with industry leaders in India to discuss the importance of maintaining high-quality standards in producing goods to ensure consumers have access to safe products," FDA wrote.
That could leave Hamburg with tough questions to answer and tougher advice to dispense during her nine-day trip to the region-her first during her tenure as FDA commissioner.
FDA Statement
Tags: Margaret Hamburg, Latest News, Hamburg
Regulatory Focus newsletters
All the biggest regulatory news and happenings.