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 30 April 2012
The US Agency for Healthcare Research and Quality (AHRQ), the federal agency charged with improving how healthcare dollars are spent, is announcing its intention to launch a registry of patient registries modeled after of its ClinicalTrials.gov website.
AHRQ explains in its Federal Register posting that patient registries, typically run by disease-specific foundations, have "specific characteristics" that the ClinicalTrials.gov website has not been able to adequately capture.
As a result, stakeholders "have noted that the system does not fully meet their needs" which has impeded the sharing of registry data.
The agency also notes the increasing use of patient registries in driving product development, even as several issues have emerged with the patient registry model, including the duplication of efforts, privacy concerns and "insufficient dissemination of findings that are not published in the peer-reviewed literature."
To solve these issues, AHRQ is proposing to establish a registry for patient registries modeled after the ClinicalTrials.gov program.
The registry, dubbed the Registry of Patient Registries (RoPR), is intended to help "further AHRQ's goals by making information regarding quality, appropriateness and effectiveness of health services (and patient registries in particular) more readily available and centralized."
AHRQ notes the RoPR will have four objectives: provide a searchable database of patient registries, improve data sharing through standardization, provide registry-run study results to the public and act as a patient-recruitment tool.
Read more:
AHRQ - Agency Information Collection Activities: Proposed Collection; Comment Request
Tags: Registries, RoPR, Patient Registry, AHRQ, Latest News, clinical trial, registry, study, clinical trials
Regulatory Focus newsletters
All the biggest regulatory news and happenings.