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 20 January 2012 | By Alexander Gaffney, RAC
Representative Bruce Braley (D-IA) introduced a new bill on 18 January that would mandate that US regulatory agencies use "plain language in developing and implementing regulations."
The bill, H.R. 3786 of the 112th congress, is titled To ensure clarity of regulations to improve the effectiveness of Federal regulatory programs while decreasing burdens on the regulated public. The bill has been referred to the Judiciary Committee for markup.
The bill aims to "improve the effectiveness and accountability of Federal agencies to the public by promoting clear regulations that are easier for the government to implement and for the public to comply with."
"Sadly, gobbledygook dominates the regulations issued by government agencies, making it almost impossible for small businesses to understand the rules of the road," Braley said in a press release.
While no specific mention of the US Food and Drug Administration (FDA) was made, the bill would still require FDA to designate senior officials to carry out the act, communicate the act to all staff, train their staff on writing regulations using clear language, establish a process for overseeing compliance with the act, and designate officials to receive public input.
The bill takes "plain language" to mean "language that is clear, concise, well-organized, and follows other best practices appropriate to the subject or field and intended audience."
Tags: Simplify, Baley, Latest News, Bill, Congress, regulations
Regulatory Focus newsletters
All the biggest regulatory news and happenings.