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.
Resources, news and special offers to support you and your professional development during this difficult time.
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.
Download your copy of the new events calendar and see all the online workshops, conferences, RAC exams and European online workshops RAPS has planned for 2021 at a glance.
Registration is now open for RAPS Euro Convergence 2021! Attend to join peers from EU and around the world to gain insights and exchange ideas on the regions most pressing issues.
An invaluable resource for any professional engaged in designing, composing, compiling, or commenting on regulatory documentation
From self-assessments to help you identify your strengths and areas to focus on to reference books and online courses that will help you fill in the gaps in your regulatory knowledge, RAPS has the resources to help you prepare for the RAC exam.
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 07 August 2015 | By Michael Mezher
Last December, the US Food and Drug Administration (FDA) released a new, dynamic search list for its more than 3,000 guidance documents. Now, the agency is touting the new search functionality as a success after seeing traffic to its guidance documents increase more than 600%.
In a post to FDA Voice, the agency's blog, Chris Mulieri, director of web and digital media for the Office of Information Management, discusses the agency's efforts to make the dynamic search possible.
Because it would not be practical for each of FDA's branches to post guidance documents to a single repository, the agency put together a working group to establish the types of search criteria that would be used. Then, each guidance was tagged with metadata, such as subject, date issued, closing date for comments and whether the document is a draft or final version. This metadata enables the search list to be filtered in ascending or descending lists.
Previously, to find guidance documents, an individual would have to navigate to one of 10 locations on FDA's website to begin their search. Now, from FDA.gov, it takes only one click on "Guidance Documents" to get to the search page.
By default, the guidance document list displays all guidance documents in order from newest to oldest. Once a user begins to type in the search field, the list is instantly narrowed to meet the search criteria. For instance, if someone was looking for FDA's recently issued guidance on quality metrics, typing the search term "quality metrics" would instantly bring up the relevant guidance.
FDA says the new guidance search has been a massive success. So far, traffic to FDA's guidance documents has surged from 22,000 page views to more than 136,000 page views in the first quarter of 2014. The agency also said its user satisfaction has increased after launching the new dynamic search function.
FDA Voice
Tags: guidance documents
Regulatory Focus newsletters
All the biggest regulatory news and happenings.